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Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00075582
Collaborator
National Cancer Institute (NCI) (NIH)
390
Enrollment
163
Locations
2
Arms
204.8
Duration (Months)
2.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and radiotherapy.
SECONDARY OBJECTIVES:
  1. Determine local control rates in patients treated with this regimen. II. Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical group
  1. and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor.
  1. Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group.

REGIMEN I (subset 1 patients) [closed to accrual as of 08/13/2010: Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin* IV over 1 minute on day 1 of weeks 13, 16, 19, and 22; and radiotherapy**, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose.

REGIMEN II (subset 2 patients)[closed to accrual as of 9/23/2011]: Patients receive VAC chemotherapy and radiotherapy** as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin* IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46. Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy, and continued VA* chemotherapy. In both regimens, treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: *For both regimens, dactinomycin is omitted during radiotherapy.

NOTE: **Clinical Group I tumors and those with Clinical Group III uterine/cervix primary disease with negative nodes who have undergone a complete resection (i.e. hysterectomy) at Week 13 do not receive radiotherapy at Week 13

Patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Study Design

Study Type:
Interventional
Actual Enrollment :
390 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
Study Start Date :
Sep 4, 2004
Actual Primary Completion Date :
Aug 13, 2012
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Regimen I (chemotherapy, radiotherapy)

Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)

Drug: dactinomycin
Given IV
Other Names:
  • ACT-D
  • actinomycin C1
  • AD
  • Cosmegen
  • DACT

    • Drug: cyclophosphamide
    Given IV
    Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana

    • Drug: vincristine sulfate
    Given IV
    Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS

    • Radiation: radiation therapy
    Undergo radiotherapy
    Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation

    		•
    Experimental: Regimen II (chemotherapy, radiotherapy, surgery)

    Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).

    Procedure: conventional surgery
    Some patients may undergo second-look surgery
    Other Names:
  • surgery, conventional

    • Drug: dactinomycin
    Given IV
    Other Names:
  • ACT-D
  • actinomycin C1
  • AD
  • Cosmegen
  • DACT

    • Drug: cyclophosphamide
    Given IV
    Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana

    • Drug: vincristine sulfate
    Given IV
    Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS

    • Radiation: radiation therapy
    Undergo radiotherapy
    Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry [From enrollment up to 5 years]

      Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.

    2. Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry [From enrollment up to 5 years]

      Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.

    3. Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry [From enrollment up to 5 years]

      Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.

    Secondary Outcome Measures

    1. Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy [From enrollment up to 5 years]

      The local failure rate will be estimated using cumulative incidence curves.

    2. Percentage of Patients With Delayed Surgical Procedures [At 13 weeks after induction]

      The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.

    3. Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose [From enrollment up to 20 weeks]

      The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets:

    • Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010):

    • Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease

    • Stage 1 and clinical group III (gross residual disease) disease arising in the orbit

    • Stage 2 and clinical group I or II disease

    • Subset 2, defined by meeting 1 of the following criteria (closed to accrual as of 09/23/2011):

    • Stage 1 and clinical group III disease arising in a non-orbit site

    • Stage 3 and clinical group I or II disease

    • Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies)

    • If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III

    • Prior regional lymph node sampling required for patients with extremity tumors

    • None of the following diagnoses:

    • Intermediate-risk embryonal RMS

    • Metastatic embryonal RMS

    • Alveolar RMS

    • Undifferentiated sarcoma

    • RMS not otherwise specified (NOS)

    • Other soft tissue sarcoma, including sarcoma NOS

    • Prior enrollment on clinical trial COG-D9902

    • Performance status - ECOG 0-2

    • Performance status - Karnofsky 50-100% (≥ 16 years old)

    • Performance status - Lansky 50-100% (< 16 years old)

    • Absolute neutrophil count at least 750/mm^3

    • Platelet count at least 75,000/mm^3 (transfusion independent)

    • Bilirubin no greater than 1.5 times upper limit of normal (ULN)*

    • Creatinine* based on age/gender as follows:

    • No greater than 0.8 mg/dL for patients age 5 and under

    • No greater than 1.0 mg/dL for patients age 6 to 9

    • No greater than 1.2 mg/dL for patients age 10 to 12

    • No greater than 1.4 mg/dL for female patients age 13 and over

    • No greater than 1.5 mg/dL for male patients age 13 to 15

    • No greater than 1.7 mg/dL for male patients age 16 and over

    • Creatinine clearance* or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No uncontrolled infection

    • No prior chemotherapy (except for patients treated on the related intermediate-risk study)

    • Prior steroids allowed

    • No prior radiotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Phoenix Childrens Hospital Phoenix Arizona United States 85016
    3 University of Arizona Health Sciences Center Tucson Arizona United States 85724
    4 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    5 Children's Oncology Group Arcadia California United States 91006-3776
    6 Southern California Permanente Medical Group Downey California United States 90242
    7 Loma Linda University Medical Center Loma Linda California United States 92354
    8 Miller Children's Hospital Long Beach California United States 90806
    9 Children's Hospital Los Angeles Los Angeles California United States 90027
    10 Cedars-Sinai Medical Center Los Angeles California United States 90048
    11 Children's Hospital Central California Madera California United States 93636-8762
    12 Children's Hospital and Research Center at Oakland Oakland California United States 94609-1809
    13 Kaiser Permanente-Oakland Oakland California United States 94611
    14 Childrens Hospital of Orange County Orange California United States 92868-3874
    15 Lucile Packard Children's Hospital Stanford University Palo Alto California United States 94304
    16 UC Davis Comprehensive Cancer Center Sacramento California United States 95817
    17 Rady Children's Hospital - San Diego San Diego California United States 92123
    18 University of California San Francisco Medical Center-Parnassus San Francisco California United States 94143
    19 Children's Hospital Colorado Aurora Colorado United States 80045
    20 Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado United States 80218
    21 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    22 Children's National Medical Center Washington District of Columbia United States 20010
    23 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    24 Memorial Healthcare System - Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    25 Nemours Children's Clinic - Jacksonville Jacksonville Florida United States 32207-8426
    26 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    27 Miami Children's Hospital Miami Florida United States 33155
    28 Baptist Hospital of Miami Miami Florida United States 33176
    29 M D Anderson Cancer Center- Orlando Orlando Florida United States 32806
    30 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
    31 All Children's Hospital Saint Petersburg Florida United States 33701
    32 Saint Joseph Children's Hospital of Tampa Tampa Florida United States 33607
    33 Saint Mary's Hospital West Palm Beach Florida United States 33407
    34 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
    35 Memorial Health University Medical Center Savannah Georgia United States 31403
    36 University of Hawaii Honolulu Hawaii United States 96813
    37 Tripler Army Medical Center Honolulu Hawaii United States 96859
    38 Saint Luke's Mountain States Tumor Institute Boise Idaho United States 83712
    39 University of Illinois Chicago Illinois United States 60612
    40 Childrens Memorial Hospital Chicago Illinois United States 60614
    41 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637-1470
    42 Advocate Hope Children's Hospital Oak Lawn Illinois United States 60453
    43 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
    44 Saint Jude Midwest Affiliate Peoria Illinois United States 61602
    45 Southern Illinois University Springfield Illinois United States 62702
    46 Indiana University Medical Center Indianapolis Indiana United States 46202
    47 Raymond Blank Children's Hospital Des Moines Iowa United States 50309
    48 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    49 University of Kentucky Lexington Kentucky United States 40536
    50 Kosair Children's Hospital Louisville Kentucky United States 40202
    51 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    52 Children's Hospital-Main Campus New Orleans Louisiana United States 70118
    53 Eastern Maine Medical Center Bangor Maine United States 04401
    54 Maine Children's Cancer Program Scarborough Maine United States 04074
    55 University of Maryland Greenebaum Cancer Center Baltimore Maryland United States 21201-1595
    56 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    57 Johns Hopkins University Baltimore Maryland United States 21287-8936
    58 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    59 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    60 Baystate Medical Center Springfield Massachusetts United States 01199
    61 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
    62 Wayne State University Detroit Michigan United States 48202
    63 Hurley Medical Center Flint Michigan United States 48502
    64 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    65 Michigan State University - Breslin Cancer Center Lansing Michigan United States 48910
    66 William Beaumont Hospital Royal Oak Michigan United States 48073
    67 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    68 University of Minnesota Medical Center-Fairview Minneapolis Minnesota United States 55455
    69 Mayo Clinic Rochester Minnesota United States 55905
    70 University of Mississippi Medical Center Jackson Mississippi United States 39216
    71 The Childrens Mercy Hospital Kansas City Missouri United States 64108
    72 Cardinal Glennon Children's Medical Center Saint Louis Missouri United States 63104
    73 Washington University School of Medicine Saint Louis Missouri United States 63110
    74 Children's Hospital and Medical Center of Omaha Omaha Nebraska United States 68114
    75 University of Nebraska Medical Center Omaha Nebraska United States 68198
    76 Nevada Cancer Research Foundation CCOP Las Vegas Nevada United States 89106
    77 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    78 Hackensack University Medical Center Hackensack New Jersey United States 07601
    79 UMDNJ - Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    80 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    81 University of New Mexico Cancer Center Albuquerque New Mexico United States 87106
    82 Albany Medical Center Albany New York United States 12208
    83 Montefiore Medical Center Bronx New York United States 10467-2490
    84 Brooklyn Hospital Center Brooklyn New York United States 11201
    85 Roswell Park Cancer Institute Buffalo New York United States 14263
    86 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    87 Mount Sinai Medical Center New York New York United States 10029
    88 Columbia University Medical Center New York New York United States 10032
    89 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    90 University of Rochester Rochester New York United States 14642
    91 State University of New York Upstate Medical University Syracuse New York United States 13210
    92 New York Medical College Valhalla New York United States 10595
    93 Mission Hospitals Inc Asheville North Carolina United States 28801
    94 University of North Carolina Chapel Hill North Carolina United States 27599
    95 Presbyterian Hospital Charlotte North Carolina United States 28204
    96 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    97 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    98 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    99 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
    100 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    101 Nationwide Children's Hospital Columbus Ohio United States 43205
    102 The Children's Medical Center of Dayton Dayton Ohio United States 45404
    103 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
    104 Oregon Health and Science University Portland Oregon United States 97239
    105 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    106 Geisinger Medical Center Danville Pennsylvania United States 17822-2001
    107 Penn State Hershey Children's Hospital Hershey Pennsylvania United States 17033
    108 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    109 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    110 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    111 Medical University of South Carolina Charleston South Carolina United States 29425
    112 Greenville Cancer Treatment Center Greenville South Carolina United States 29605
    113 T C Thompson Children's Hospital Chattanooga Tennessee United States 37403
    114 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    115 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    116 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
    117 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    118 Medical City Dallas Hospital Dallas Texas United States 75230
    119 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    120 Cook Children's Medical Center Fort Worth Texas United States 76104
    121 Baylor College of Medicine Houston Texas United States 77030
    122 M D Anderson Cancer Center Houston Texas United States 77030
    123 Covenant Children's Hospital Lubbock Texas United States 79410
    124 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900
    125 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
    126 Scott and White Memorial Hospital Temple Texas United States 76508
    127 Primary Children's Medical Center Salt Lake City Utah United States 84113
    128 University of Vermont Burlington Vermont United States 05401
    129 University of Virginia Charlottesville Virginia United States 22908
    130 Inova Fairfax Hospital Falls Church Virginia United States 22042
    131 Childrens Hospital-King's Daughters Norfolk Virginia United States 23507
    132 Virginia Commonwealth University Richmond Virginia United States 23298
    133 Seattle Children's Hospital Seattle Washington United States 98105
    134 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    135 West Virginia University Charleston Charleston West Virginia United States 25304
    136 Saint Vincent Hospital Green Bay Wisconsin United States 54301
    137 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    138 Midwest Children's Cancer Center Milwaukee Wisconsin United States 53226
    139 Sydney Children's Hospital Randwick New South Wales Australia 2031
    140 The Children's Hospital at Westmead Sydney New South Wales Australia 2145
    141 Sydney West Area Health Service-Westmead Hospital Westmead New South Wales Australia 2145
    142 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
    143 Women's and Children's Hospital-Adelaide North Adelaide South Australia Australia 5006
    144 Royal Children's Hospital Parkville Victoria Australia 3052
    145 Princess Margaret Hospital for Children Perth Western Australia Australia 6008
    146 Alberta Children's Hospital Calgary Alberta Canada T3B 6A8
    147 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    148 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
    149 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    150 Janeway Child Health Centre Saint John's Newfoundland and Labrador Canada A1B 3V6
    151 Chedoke-McMaster Hospitals Hamilton Ontario Canada L8S 4L8
    152 Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Ontario Canada K7L 5P9
    153 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    154 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    155 The Montreal Children's Hospital of the MUHC Montreal Quebec Canada H3H 1P3
    156 Hospital Sainte-Justine Montreal Quebec Canada H3T 1C5
    157 Centre Hospitalier Universitaire de Quebec Ste-Foy Quebec Canada G1V 4G2
    158 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    159 Starship Children's Hospital Grafton Auckland New Zealand 1145
    160 Christchurch Hospital Christchurch New Zealand 8011
    161 San Jorge Children's Hospital Santurce Puerto Rico 00912
    162 Swiss Pediatric Oncology Group - Geneva Geneva Switzerland 1205
    163 Swiss Pediatric Oncology Group - Lausanne Lausanne Switzerland 1011

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: David Walterhouse, MD, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00075582
    Other Study ID Numbers:
    • ARST0331
    • NCI-2009-00425
    • COG-ARST0331
    • CDR0000347078
    • U10CA098543
    First Posted:
    Jan 12, 2004
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Rhabdomyosarcoma
    Rhabdomyosarcoma, Embryonal
    Dactinomycin
    Cactinomycin
    Cyclophosphamide
    Vincristine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Regimen I (Chemotherapy, Radiotherapy) Regimen II (Chemotherapy, Radiotherapy, Surgery)
    Arm/Group Description Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
    Period Title: Overall Study
    STARTED 305 85
    COMPLETED 255 50
    NOT COMPLETED 50 35

    Baseline Characteristics

    Arm/Group Title Regimen I (Chemotherapy, Radiotherapy) Regimen II (Chemotherapy, Radiotherapy, Surgery) Total
    Arm/Group Description Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy Total of all reporting groups
    Overall Participants 305 85 390
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    7.69
    (5.81)
    5.02
    (6.78)
    7.11
    (6.13)
    Sex: Female, Male (Count of Participants)
    Female
    88
    28.9%
    55
    64.7%
    143
    36.7%
    Male
    217
    71.1%
    30
    35.3%
    247
    63.3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    0.7%
    2
    2.4%
    4
    1%
    Asian
    9
    3%
    2
    2.4%
    11
    2.8%
    Native Hawaiian or Other Pacific Islander
    1
    0.3%
    0
    0%
    1
    0.3%
    Black or African American
    39
    12.8%
    9
    10.6%
    48
    12.3%
    White
    228
    74.8%
    65
    76.5%
    293
    75.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    26
    8.5%
    7
    8.2%
    33
    8.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    38
    12.5%
    9
    10.6%
    47
    12.1%
    Not Hispanic or Latino
    255
    83.6%
    71
    83.5%
    326
    83.6%
    Unknown or Not Reported
    12
    3.9%
    5
    5.9%
    17
    4.4%
    Region of Enrollment (participants) [Number]
    United States
    269
    88.2%
    77
    90.6%
    346
    88.7%
    Canada
    21
    6.9%
    5
    5.9%
    26
    6.7%
    Australia
    7
    2.3%
    3
    3.5%
    10
    2.6%
    Netherlands
    2
    0.7%
    0
    0%
    2
    0.5%
    New Zealand
    1
    0.3%
    0
    0%
    1
    0.3%
    Puerto Rico
    2
    0.7%
    0
    0%
    2
    0.5%
    Switzerland
    3
    1%
    0
    0%
    3
    0.8%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry
    Description Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
    Time Frame From enrollment up to 5 years

    Outcome Measure Data

    Analysis Population Description
    Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
    Arm/Group Title Regimen I (Chemotherapy, Radiotherapy) Regimen II (Chemotherapy, Radiotherapy, Surgery)
    Arm/Group Description Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
    Measure Participants 269 69
    Number (95% Confidence Interval) [Estimated percentage of participants]
    87
    28.5%
    67
    78.8%
    2. Primary Outcome
    Title Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry
    Description Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
    Time Frame From enrollment up to 5 years

    Outcome Measure Data

    Analysis Population Description
    All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.
    Arm/Group Title Regimen I (Chemotherapy, Radiotherapy)
    Arm/Group Description Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
    Measure Participants 30
    Number (95% Confidence Interval) [Estimated percentage of participants]
    90
    29.5%
    3. Primary Outcome
    Title Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
    Description Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
    Time Frame From enrollment up to 5 years

    Outcome Measure Data

    Analysis Population Description
    All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.
    Arm/Group Title Regimen II (Chemotherapy, Radiotherapy, Surgery)
    Arm/Group Description Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
    Measure Participants 69
    Number (95% Confidence Interval) [Estimated percentage of participants]
    67
    22%
    4. Secondary Outcome
    Title Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy
    Description The local failure rate will be estimated using cumulative incidence curves.
    Time Frame From enrollment up to 5 years

    Outcome Measure Data

    Analysis Population Description
    Patients who received reduced doses of radiation therapy.
    Arm/Group Title Regimen I (Chemotherapy, Radiotherapy) Regimen II (Chemotherapy, Radiotherapy, Surgery)
    Arm/Group Description Stage I/II group IIA patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy Group III patients with orbit primary receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
    Measure Participants 52 62
    Number (95% Confidence Interval) [stimated percentage of participants]
    0.081
    0%
    0.115
    0.1%
    5. Secondary Outcome
    Title Percentage of Patients With Delayed Surgical Procedures
    Description The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.
    Time Frame At 13 weeks after induction

    Outcome Measure Data

    Analysis Population Description
    All eligible Stage I Group III nonorbit primary and stage III group I/II patients
    Arm/Group Title Regimen II (Stage I Group III Nonorbit or Stage III Group I/II
    Arm/Group Description Stage I group III nonorbit primary or stage III group I/II patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
    Measure Participants 45
    Number (95% Confidence Interval) [percentage of participants]
    0.49
    0.2%
    6. Secondary Outcome
    Title Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose
    Description The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection.
    Time Frame From enrollment up to 20 weeks

    Outcome Measure Data

    Analysis Population Description
    Patients with Group III vaginal primary tumor
    Arm/Group Title Regimen II (Stage I Group III Nonorbit or Stage III Group I/II
    Arm/Group Description Stage I group III nonorbit primary or stage III group I/II patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
    Measure Participants 5
    Number [Estimated percentage of participants]
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
    Arm/Group Title Regimen I (Chemotherapy, Radiotherapy) Regimen II (Chemotherapy, Radiotherapy, Surgery)
    Arm/Group Description Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
    All Cause Mortality
    Regimen I (Chemotherapy, Radiotherapy) Regimen II (Chemotherapy, Radiotherapy, Surgery)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Regimen I (Chemotherapy, Radiotherapy) Regimen II (Chemotherapy, Radiotherapy, Surgery)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/272 (0.4%) 1/70 (1.4%)
    Investigations
    Neutrophil count decreased 0/272 (0%) 1/70 (1.4%) 1
    White blood cell decreased 1/272 (0.4%) 1 0/70 (0%) 1
    Other (Not Including Serious) Adverse Events
    Regimen I (Chemotherapy, Radiotherapy) Regimen II (Chemotherapy, Radiotherapy, Surgery)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 74/272 (27.2%) 27/70 (38.6%)
    Blood and lymphatic system disorders
    Anemia 14/272 (5.1%) 14 9/70 (12.9%) 9
    Disseminated intravascular coagulation 1/272 (0.4%) 1 0/70 (0%) 1
    Febrile neutropenia 14/272 (5.1%) 14 7/70 (10%) 7
    Cardiac disorders
    Sinus tachycardia 1/272 (0.4%) 1 0/70 (0%) 1
    Eye disorders
    Photophobia 1/272 (0.4%) 1 0/70 (0%) 1
    Watering eyes 1/272 (0.4%) 1 0/70 (0%) 1
    Gastrointestinal disorders
    Abdominal pain 2/272 (0.7%) 2 1/70 (1.4%) 1
    Constipation 3/272 (1.1%) 3 1/70 (1.4%) 1
    Diarrhea 1/272 (0.4%) 1 0/70 (0%) 1
    Flatulence 1/272 (0.4%) 1 0/70 (0%) 1
    Ileus 1/272 (0.4%) 1 0/70 (0%) 1
    Mucositis oral 2/272 (0.7%) 2 2/70 (2.9%) 2
    Nausea 3/272 (1.1%) 3 0/70 (0%) 3
    Oral pain 1/272 (0.4%) 1 0/70 (0%) 1
    Small intestinal obstruction 0/272 (0%) 1/70 (1.4%) 1
    Vomiting 5/272 (1.8%) 5 0/70 (0%) 5
    General disorders
    Facial pain 1/272 (0.4%) 1 0/70 (0%) 1
    Fatigue 1/272 (0.4%) 1 0/70 (0%) 1
    Fever 5/272 (1.8%) 5 4/70 (5.7%) 4
    Non-cardiac chest pain 1/272 (0.4%) 1 0/70 (0%) 0
    Pain 2/272 (0.7%) 2 1/70 (1.4%) 1
    Hepatobiliary disorders
    Hepatobiliary disorders - Other 2/272 (0.7%) 2 0/70 (0%) 0
    Infections and infestations
    Catheter related infection 2/272 (0.7%) 2 1/70 (1.4%) 1
    Conjunctivitis infective 1/272 (0.4%) 1 0/70 (0%) 0
    Infections and infestations - Other 4/272 (1.5%) 4 5/70 (7.1%) 5
    Rhinitis infective 1/272 (0.4%) 1 0/70 (0%) 0
    Upper respiratory infection 1/272 (0.4%) 1 0/70 (0%) 0
    Urinary tract infection 2/272 (0.7%) 2 2/70 (2.9%) 2
    Injury, poisoning and procedural complications
    Dermatitis radiation 1/272 (0.4%) 1 0/70 (0%) 0
    Investigations
    Alanine aminotransferase increased 9/272 (3.3%) 9 2/70 (2.9%) 2
    Alkaline phosphatase increased 0/272 (0%) 0 1/70 (1.4%) 1
    Aspartate aminotransferase increased 7/272 (2.6%) 7 3/70 (4.3%) 3
    Blood bilirubin increased 2/272 (0.7%) 2 0/70 (0%) 2
    Creatinine increased 1/272 (0.4%) 1 1/70 (1.4%) 1
    Lymphocyte count decreased 2/272 (0.7%) 2 3/70 (4.3%) 3
    Neutrophil count decreased 43/272 (15.8%) 43 15/70 (21.4%) 15
    Platelet count decreased 10/272 (3.7%) 10 1/70 (1.4%) 1
    Weight loss 2/272 (0.7%) 2 3/70 (4.3%) 3
    White blood cell decreased 23/272 (8.5%) 23 10/70 (14.3%) 10
    Metabolism and nutrition disorders
    Anorexia 0/272 (0%) 0 1/70 (1.4%) 1
    Hypercalcemia 1/272 (0.4%) 1 0/70 (0%) 1
    Hyperglycemia 4/272 (1.5%) 4 4/70 (5.7%) 4
    Hyperkalemia 0/272 (0%) 1/70 (1.4%) 1
    Hypoalbuminemia 1/272 (0.4%) 1 0/70 (0%) 1
    Hypocalcemia 1/272 (0.4%) 1 0/70 (0%) 1
    Hypokalemia 1/272 (0.4%) 1 1/70 (1.4%) 1
    Hyponatremia 1/272 (0.4%) 1 0/70 (0%) 1
    Musculoskeletal and connective tissue disorders
    Muscle weakness upper limb 1/272 (0.4%) 1 0/70 (0%) 1
    Neck pain 1/272 (0.4%) 1 0/70 (0%) 1
    Nervous system disorders
    Headache 1/272 (0.4%) 1 0/70 (0%) 1
    Peripheral motor neuropathy 4/272 (1.5%) 4 1/70 (1.4%) 1
    Peripheral sensory neuropathy 4/272 (1.5%) 4 1/70 (1.4%) 1
    Pyramidal tract syndrome 1/272 (0.4%) 1 0/70 (0%) 1
    Reproductive system and breast disorders
    Scrotal pain 1/272 (0.4%) 1 0/70 (0%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 0/272 (0%) 1/70 (1.4%) 1
    Skin and subcutaneous tissue disorders
    Alopecia 1/272 (0.4%) 1 0/70 (0%) 1
    Skin and subcutaneous tissue disorders - Other, specify 3/272 (1.1%) 3 0/70 (0%) 3
    Skin hyperpigmentation 2/272 (0.7%) 2 0/70 (0%) 2
    Skin hypopigmentation 1/272 (0.4%) 1 0/70 (0%) 1
    Vascular disorders
    Vascular disorders - Other 0/272 (0%) 1/70 (1.4%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Must obtain prior Sponsor approval.

    Results Point of Contact

    Name/Title Results Reporting Coordinator
    Organization Children's Oncology Group
    Phone 626-447-0064
    Email resultsreportingcoordinator@childrensoncologygroup.org
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00075582
    Other Study ID Numbers:
    • ARST0331
    • NCI-2009-00425
    • COG-ARST0331
    • CDR0000347078
    • U10CA098543
    First Posted:
    Jan 12, 2004
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021