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Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00011960
Collaborator
National Cancer Institute (NCI) (NIH)
69
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel use 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. Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and radiation therapy with or without fluorouracil in treating patients who have stage IB, stage IIB, or stage IIIB stomach cancer that has been removed during surgery.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric cancer treated with cisplatin, paclitaxel, and radiotherapy with or without fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 (RTOG 90-18). (Arm I closed to accrual as of 6/18/03.)

  • Compare the safety and success of these regimens vs therapy in the intergroup adjuvant study.

  • Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the intergroup study.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more). Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of 6/18/03.)

  • Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on days 1 and 29.

At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.

  • Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days 1 and 29.

At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.

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

PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers
Study Start Date :
May 1, 2001
Actual Primary Completion Date :
May 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor

    • No more than 8 weeks since primary tumor resection

    • No metastatic disease

    PATIENT CHARACTERISTICS:
    Age:
    • Not specified
    Performance status:
    • Zubrod 0-1
    Life expectancy:
    • Not specified
    Hematopoietic:

    • WBC (white blood cell count) at least 4,000/mm^3

    • Platelet count at least 150,000/mm^3

    Hepatic:

    • Bilirubin no greater than 1.5 mg/dL

    • AST (aspartate aminotransferase) and ALT (alanine amino transferase) no greater than 2.5 times upper limit of normal

    Renal:

    • BUN(blood urea nitrogen)less than 30 mg/dL

    • Creatinine no greater than 1.4 mg/dL

    • Creatinine clearance greater than 50 mL/min

    Cardiovascular:

    • No New York Heart Association class III or IV heart disease

    • No active angina or myocardial infarction within the past 6 months

    • No history of significant ventricular arrhythmia requiring medication with antiarrhythmics

    • No history of clinically significant conduction system abnormality

    Other:

    • No concurrent serious infection that is uncontrolled or would preclude study participation

    • No nonmalignant medical illness that is uncontrolled or would preclude study participation

    • No psychiatric disorders that would preclude study participation

    • No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

    • No clinically significant hearing loss

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:

    • No prior chemotherapy

    • No other concurrent chemotherapy

    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • No prior radiotherapy to the treatment field
    Surgery:
    • See Disease Characteristics
    Other:
    • No other concurrent anticancer therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 Mobile Infirmary Medical Center Mobile Alabama United States 36652-2144
    3 Providence Alaska Medical Center Anchorage Alaska United States 99519-6604
    4 Foundation for Cancer Research and Education Phoenix Arizona United States 85013
    5 Providence Saint Joseph Medical Center - Burbank Burbank California United States 91505
    6 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    7 Sutter Health Western Division Cancer Research Group Greenbrae California United States 94904
    8 Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda California United States 92354
    9 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    10 University of California Davis Cancer Center Sacramento California United States 95817
    11 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    12 Memorial Hospital Cancer Center Colorado Springs Colorado United States 80909
    13 University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver Colorado United States 80010
    14 Yale Comprehensive Cancer Center New Haven Connecticut United States 06520-8040
    15 Baptist Hospital of Miami Miami Florida United States 33256-2110
    16 Alexian Brothers Cancer Care Center Elk Grove Village Illinois United States 60007
    17 Wendt Regional Cancer Center of Finley Hospital Dubuque Iowa United States 52001
    18 Cancer Center at Lexington Clinic Lexington Kentucky United States 40504
    19 Cancer Research Center at Boston Medical Center Boston Massachusetts United States 02118
    20 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    21 CCOP - Kansas City Kansas City Missouri United States 64131
    22 Siteman Cancer Center Saint Louis Missouri United States 63110
    23 Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha Omaha Nebraska United States 68114-4199
    24 John F. Kennedy Medical Center Edison New Jersey United States 08818
    25 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Mount Holly New Jersey United States 08060
    26 Community Medical Center Toms River New Jersey United States 08755
    27 New York Methodist Hospital Brooklyn New York United States 11215
    28 Highland Hospital of Rochester Rochester New York United States 14620
    29 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
    30 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
    31 Wayne Memorial Hospital, Inc. Goldsboro North Carolina United States 27533
    32 Rutherford Hospital Rutherfordton North Carolina United States 28139-0000
    33 Akron General Medical Center Akron Ohio United States 44302
    34 Akron City Hospital - Summa Health System Akron Ohio United States 44304
    35 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    36 CCOP - Dayton Dayton Ohio United States 45429
    37 Blanchard Valley Medical Associates Findlay Ohio United States 45840
    38 Lima Memorial Hospital Lima Ohio United States 45804
    39 St. Charles Hospital Oregon Ohio United States 43616
    40 Cancer Care Center, Incorporated Salem Ohio United States 44460
    41 Firelands Regional Medical Center Sandusky Ohio United States 44870
    42 Flower Hospital - ProMedica Health System Sylvania Ohio United States 43560
    43 Medical College of Ohio Cancer Institute Toledo Ohio United States 43614
    44 CCOP - Toledo Community Hospital Toledo Ohio United States 43623-3456
    45 Fulton County Health Center Wauseon Ohio United States 43567
    46 Natalie Warren Bryant Cancer Center Tulsa Oklahoma United States 74136
    47 John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital Allentown Pennsylvania United States 18105
    48 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    49 Mercy Fitzgerald Hospital Darby Pennsylvania United States 19023
    50 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
    51 Pocono Cancer Center East Stroudsburg Pennsylvania United States 18301
    52 Paoli Memorial Hospital Paoli Pennsylvania United States 19301-1792
    53 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    54 Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224
    55 Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania United States 19096
    56 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    57 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    58 Cottonwood Hospital Medical Center Murray Utah United States 84107
    59 McKay-Dee Hospital Center Ogden Utah United States 84403
    60 Dixie Regional Medical Center Saint George Utah United States 84770
    61 University of Utah Health Sciences Center Salt Lake City Utah United States 84132
    62 LDS Hospital Salt Lake City Utah United States 84143
    63 University of Washington Medical Center Seattle Washington United States 98195-6043
    64 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54301
    65 St. Vincent Hospital Green Bay Wisconsin United States 54307-3508
    66 CCOP - Marshfield Clinic Research Foundation Marshfield Wisconsin United States 54449
    67 Columbia Hospital Milwaukee Wisconsin United States 53211
    68 St. Luke's Medical Center Milwaukee Wisconsin United States 53215
    69 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Radiation Therapy Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: David Paul Kelsen, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radiation Therapy Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00011960
    Other Study ID Numbers:
    • RTOG-G-0114
    • CDR0000068464
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Nov 17, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Radiation Therapy Oncology Group
    stage I gastric cancer
    stage II gastric cancer
    stage III gastric cancer
    stage I esophageal cancer
    stage II esophageal cancer
    stage III esophageal cancer
    adenocarcinoma of the stomach
    adenocarcinoma of the esophagus
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Esophageal Neoplasms
    Paclitaxel
    Cisplatin

    Study Results

    No Results Posted as of Nov 17, 2015