TAILOR RT: Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
Sponsor
Canadian Cancer Trials Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT03488693
Collaborator
Alliance for Clinical Trials in Oncology (Other), Eastern Cooperative Oncology Group (Other), NRG Oncology (Other), Southwest Oncology Group (Other)
2,140
357
2
115
6
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). No one really knows whether patients with low risk breast cancer need to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not need it. These women may be exposed to the side effects of their treatment without benefit.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
2140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
Actual Study Start Date
:
May 30, 2018
Anticipated Primary Completion Date
:
Sep 1, 2027
Anticipated Study Completion Date
:
Dec 30, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: No Regional Radiotherapy A. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy |
Radiation: Radiation
Radiotherapy given
Other: No Radiation
No radiotherapy given
|
| Active Comparator: Regional Radiotherapy A. WBI plus RT to the regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following BCS or; B. RT to the chestwall and regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following mastectomy |
Radiation: Radiation
Radiotherapy given
|
Outcome Measures
Primary Outcome Measures
- compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not [9.5 years]
Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.
Secondary Outcome Measures
- Compare the invasive disease-free survival between patients that received regional RT or not. [9.5 years]
Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC
- Compare the breast cancer mortality between patients that received regional RT or not. [9.5 years]
Defined as death due to BC
- Compare the overall survival (OS) between patients that received regional RT or not [9.5 years]
Defined as the time from randomization to the time of death from any cause
- Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not. [9.5 years]
Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast or regional nodes, or death to due to BC
- Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not. [9.5 years]
Defined as time from randomization to time of invasive recurrent disease in distant sites or death due to BC
- Number and severity of adverse events using the current CTCAE version 4 [9.5 years]
- Compare arm volume and mobility measurements between patients that received regional RT or not [9.5 years]
A Fisher's Exact Test will be used to compare lymphedema and arm abduction deficit between two arms. Defined as a difference in arm abduction of 10% or greater in the comparison of the ipsilateral to the contralateral arm.
- Compare patient-reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not [9.5 years]
using the NSABP Questionnaire for patients treated by BCS or mastectomy.
- Compare the quality of life (QOL) between patients that received regional RT or not [9.5 years]
Overall QOL (EORTC QLQ-C30) will be compared between the two treatment groups using a similar approach.
- Compare the cost-effectiveness between patients that received regional RT or not [9.5 years]
Costs will be expressed in $US and $CAN base currencies based on the final year of the study. An average cost per study subject by treatment arm for an overall mean cost per study arm will be generated
- Compare the quality of life (QOL) between patients that received regional RT or not [9.5 years]
breast symptoms (NSABP B32 Questionnaire) will be compared between the two treatment groups using a similar approach.
- Compare the quality of life (QOL) between patients that received regional RT or not [9.5 years]
skin symptoms and fatigue (EORTC QLQ-BR23) will be compared between the two treatment groups using a similar approach.
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care.
-
Patients must have been treated by BCS or mastectomy with clear margins of excision. Post-mastectomy positive margins for invasive disease and/or DCIS is not allowed. Multifocal disease (i.e. the presence of two or more foci or breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed.
-
Patients with T3N0 disease are eligible.
-
Patients with disease limited to nodal micrometastases are eligible
-
Patients with nodal macrometastases (>2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm).
-
Patients treated by mastectomy and SLNB alone must have only 1-2 positive axillary nodes (macrometastases, > 2 mm).
-
Patients must be ER ≥ 1% and HER2 negative on local testing
-
Patients must have an Oncotype DX recurrence score ≤25 obtained from testing of breast tumour tissue from a core biopsy or from the surgical specimen.
-
Patient must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted
-
Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted.
-
Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT.
-
Patients may or may not have had adjuvant chemotherapy.
-
RT must be administered within 16 weeks of definitive surgery if the patient is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 12 weeks after the last dose. (Note: adjuvant chemotherapy may be ongoing at the time of randomization). Definitive surgery is defined as the last breast cancer-related surgery.
-
Patient's ECOG performance status must be 0, 1 or 2.
-
Patient's age must be ≥ 35 years.
-
For the first 736 eligible English or French-speaking subjects who have agreed to optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life, health utilities and lost productivity questionnaires in either English or French
-
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements
-
Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
-
In accordance with CCTG policy, protocol treatment is to begin within 6 weeks of patient randomization.
-
Women of childbearing potential must have agreed to use an effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months.
Exclusion Criteria:
-
Patients with nodal disease limited to isolated tumour cells (pN0i+ < 0.2 mm).
-
Patients with pT3N1 and pT4 disease (Note: patients with T3N0 are eligible).
-
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
-
Synchronous or previous contralateral invasive breast cancer. (Patients with contralateral DCIS are eligible unless previously treated with radiation.)
-
History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years.
-
Patients who are pregnant.
-
Patients that have had prior ipsilateral chestwall/thoracic radiation.
-
Patients treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted.
-
Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.) which would preclude RT.
-
Patients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fairbanks Memorial Hospital | Fairbanks | Alaska | United States | 99701 |
| 2 | University of Arizona Cancer Center-Orange Grove Campus | Tucson | Arizona | United States | 85704 |
| 3 | University of Arizona Cancer Center-North Campus | Tucson | Arizona | United States | 85719 |
| 4 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 5 | Kaiser Permanente-Anaheim | Anaheim | California | United States | 92806 |
| 6 | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | United States | 94704 |
| 7 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
| 8 | Kaiser Permanente Dublin | Dublin | California | United States | 94568 |
| 9 | Fresno Cancer Center | Fresno | California | United States | 93720 |
| 10 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 11 | Los Angeles County-USC Medical Center | Los Angeles | California | United States | 90033 |
| 12 | USC / Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
| 13 | Providence Queen of The Valley | Napa | California | United States | 94558 |
| 14 | Kaiser Permanente Oakland-Broadway | Oakland | California | United States | 94611 |
| 15 | Saint Joseph Hospital - Orange | Orange | California | United States | 92868 |
| 16 | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 17 | Desert Regional Medical Center | Palm Springs | California | United States | 92262 |
| 18 | Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California | United States | 95670 |
| 19 | Rohnert Park Cancer Center | Rohnert Park | California | United States | 94928 |
| 20 | The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | United States | 95678 |
| 21 | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | United States | 95051 |
| 22 | Saint John's Cancer Institute | Santa Monica | California | United States | 90404 |
| 23 | City of Hope South Pasadena | South Pasadena | California | United States | 91030 |
| 24 | Kaiser Permanente Cancer Treatment Center | South San Francisco | California | United States | 94080 |
| 25 | Sutter Solano Medical Center/Cancer Center | Vallejo | California | United States | 94589 |
| 26 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 27 | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | United States | 80907 |
| 28 | UCHealth Memorial Hospital Central | Colorado Springs | Colorado | United States | 80909 |
| 29 | Memorial Hospital North | Colorado Springs | Colorado | United States | 80920 |
| 30 | UCHealth - Cherry Creek | Denver | Colorado | United States | 80206 |
| 31 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
| 32 | Poudre Valley Hospital | Fort Collins | Colorado | United States | 80524 |
| 33 | SCL Health Cancer Centers of Colorado - Lutheran Medical Center | Golden | Colorado | United States | 80401 |
| 34 | North Colorado Medical Center | Greeley | Colorado | United States | 80631 |
| 35 | UCHealth Greeley Hospital | Greeley | Colorado | United States | 80631 |
| 36 | UCHealth Highlands Ranch Hospital | Highlands Ranch | Colorado | United States | 80129 |
| 37 | Littleton Adventist Hospital | Littleton | Colorado | United States | 80122 |
| 38 | McKee Medical Center | Loveland | Colorado | United States | 80539 |
| 39 | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
| 40 | Smilow Cancer Hospital Care Center - Guiford | Guilford | Connecticut | United States | 06437 |
| 41 | Smilow Cancer Hospital-Hamden Care Center | Hamden | Connecticut | United States | 06518 |
| 42 | Yale University | New Haven | Connecticut | United States | 06520 |
| 43 | Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | United States | 06611 |
| 44 | Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut | United States | 06385 |
| 45 | Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 46 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
| 47 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 48 | MedStar Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 49 | Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
| 50 | Boca Raton Regional Hospital | Boca Raton | Florida | United States | 33486 |
| 51 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 52 | UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | United States | 33146 |
| 53 | UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | United States | 33442 |
| 54 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 55 | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | United States | 33021 |
| 56 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
| 57 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 58 | Miami Cancer Institute | Miami | Florida | United States | 33176 |
| 59 | Orlando Health Cancer Institute | Orlando | Florida | United States | 32806 |
| 60 | Memorial Hospital West | Pembroke Pines | Florida | United States | 33028 |
| 61 | Saint Anthony's Hospital Cancer Care Center | Saint Petersburg | Florida | United States | 33705 |
| 62 | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | United States | 33607 |
| 63 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 64 | Cleveland Clinic-Weston | Weston | Florida | United States | 33331 |
| 65 | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | United States | 31405 |
| 66 | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | United States | 83706 |
| 67 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 68 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 69 | University of Illinois | Chicago | Illinois | United States | 60612 |
| 70 | Swedish Covenant Hospital | Chicago | Illinois | United States | 60625 |
| 71 | Advocate Illinois Masonic Medical Center | Chicago | Illinois | United States | 60657 |
| 72 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 73 | Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | United States | 60115 |
| 74 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 75 | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | United States | 60201 |
| 76 | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | United States | 60134 |
| 77 | NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois | United States | 60026 |
| 78 | Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | United States | 60045 |
| 79 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 80 | Advocate Lutheran General Hospital | Park Ridge | Illinois | United States | 60068 |
| 81 | OSF Saint Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 82 | SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois | United States | 61114 |
| 83 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 84 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 85 | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | United States | 60555 |
| 86 | IU Health West Hospital | Avon | Indiana | United States | 46123 |
| 87 | IU Health North Hospital | Carmel | Indiana | United States | 46032 |
| 88 | IU Health Central Indiana Cancer Centers-Fishers | Fishers | Indiana | United States | 46037 |
| 89 | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 90 | IU Health Methodist Hospital | Indianapolis | Indiana | United States | 46202 |
| 91 | Community Cancer Center East | Indianapolis | Indiana | United States | 46219 |
| 92 | Community Cancer Center South | Indianapolis | Indiana | United States | 46227 |
| 93 | Community Cancer Center North | Indianapolis | Indiana | United States | 46256 |
| 94 | IU Health Ball Memorial Hospital | Muncie | Indiana | United States | 47303 |
| 95 | Mercy Cancer Center-West Lakes | Clive | Iowa | United States | 50325 |
| 96 | Greater Regional Medical Center | Creston | Iowa | United States | 50801 |
| 97 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 98 | Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 99 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
| 100 | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | United States | 66210 |
| 101 | Ascension Via Christi Hospitals Wichita | Wichita | Kansas | United States | 67214 |
| 102 | Saint Elizabeth Medical Center South | Edgewood | Kentucky | United States | 41017 |
| 103 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 104 | The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | United States | 40202 |
| 105 | LSU Health Sciences Center at Shreveport | Shreveport | Louisiana | United States | 71103 |
| 106 | MaineHealth Coastal Cancer Treatment Center | Bath | Maine | United States | 04530 |
| 107 | Lafayette Family Cancer Center-EMMC | Brewer | Maine | United States | 04412 |
| 108 | Maine Medical Center-Bramhall Campus | Portland | Maine | United States | 04102 |
| 109 | MaineHealth Cancer Care Center of York County | Sanford | Maine | United States | 04073 |
| 110 | Maine Medical Center- Scarborough Campus | Scarborough | Maine | United States | 04074 |
| 111 | Anne Arundel Medical Center | Annapolis | Maryland | United States | 21401 |
| 112 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
| 113 | Saint Agnes Hospital | Baltimore | Maryland | United States | 21229 |
| 114 | MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland | United States | 21237 |
| 115 | MedStar Good Samaritan Hospital | Baltimore | Maryland | United States | 21239 |
| 116 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 117 | Suburban Hospital | Bethesda | Maryland | United States | 20814 |
| 118 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 119 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 120 | Lahey Hospital and Medical Center | Burlington | Massachusetts | United States | 01805 |
| 121 | Lowell General Hospital | Lowell | Massachusetts | United States | 01854 |
| 122 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
| 123 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
| 124 | Beaumont Hospital - Dearborn | Dearborn | Michigan | United States | 48124 |
| 125 | Beaumont Hospital - Farmington Hills | Farmington Hills | Michigan | United States | 48336 |
| 126 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
| 127 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 128 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 129 | Mercy Health Mercy Campus | Muskegon | Michigan | United States | 49444 |
| 130 | Ascension Providence Hospitals - Novi | Novi | Michigan | United States | 48374 |
| 131 | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 132 | Ascension Providence Hospitals - Southfield | Southfield | Michigan | United States | 48075 |
| 133 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 134 | William Beaumont Hospital - Troy | Troy | Michigan | United States | 48085 |
| 135 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 136 | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | United States | 56601 |
| 137 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 138 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
| 139 | Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi | United States | 38671 |
| 140 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
| 141 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
| 142 | University of Kansas Cancer Center - North | Kansas City | Missouri | United States | 64154 |
| 143 | University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | United States | 64064 |
| 144 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
| 145 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
| 146 | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | United States | 59701 |
| 147 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 148 | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
| 149 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 150 | New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire | United States | 03301 |
| 151 | Wentworth-Douglass Hospital | Dover | New Hampshire | United States | 03820 |
| 152 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 153 | Solinsky Center for Cancer Care | Manchester | New Hampshire | United States | 03103 |
| 154 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 155 | Englewood Hospital and Medical Center | Englewood | New Jersey | United States | 07631 |
| 156 | The Cancer Institute of New Jersey Hamilton | Hamilton | New Jersey | United States | 08690 |
| 157 | Memorial Sloan Kettering Monmouth | Middletown | New Jersey | United States | 07748 |
| 158 | Memorial Sloan Kettering Bergen | Montvale | New Jersey | United States | 07645 |
| 159 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 160 | Sidney Kimmel Cancer Center Washington Township | Sewell | New Jersey | United States | 08080 |
| 161 | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | United States | 08876 |
| 162 | Community Medical Center | Toms River | New Jersey | United States | 08755 |
| 163 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 164 | Lovelace Radiation Oncology | Albuquerque | New Mexico | United States | 87109 |
| 165 | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | United States | 87109 |
| 166 | Memorial Medical Center - Las Cruces | Las Cruces | New Mexico | United States | 88011 |
| 167 | Montefiore Medical Center-Einstein Campus | Bronx | New York | United States | 10461 |
| 168 | Montefiore Medical Center - Moses Campus | Bronx | New York | United States | 10467 |
| 169 | New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | United States | 11215 |
| 170 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 171 | Mary Imogene Bassett Hospital | Cooperstown | New York | United States | 13326 |
| 172 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 173 | Mount Sinai Union Square | New York | New York | United States | 10003 |
| 174 | Mount Sinai Chelsea | New York | New York | United States | 10011 |
| 175 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
| 176 | Mount Sinai Hospital | New York | New York | United States | 10029 |
| 177 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 178 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 179 | Nyack Hospital | Nyack | New York | United States | 10960 |
| 180 | Rochester General Hospital | Rochester | New York | United States | 14621 |
| 181 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 182 | Memorial Sloan Kettering Nassau | Uniondale | New York | United States | 11553 |
| 183 | Mission Hospital | Asheville | North Carolina | United States | 28801 |
| 184 | Hope Women's Cancer Centers-Asheville | Asheville | North Carolina | United States | 28816 |
| 185 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 186 | CaroMont Regional Medical Center | Gastonia | North Carolina | United States | 28054 |
| 187 | Sanford Bismarck Medical Center | Bismarck | North Dakota | United States | 58501 |
| 188 | Altru Cancer Center | Grand Forks | North Dakota | United States | 58201 |
| 189 | Cleveland Clinic Akron General | Akron | Ohio | United States | 44307 |
| 190 | UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | United States | 44122 |
| 191 | Cleveland Clinic Mercy Hospital | Canton | Ohio | United States | 44708 |
| 192 | Aultman Health Foundation | Canton | Ohio | United States | 44710 |
| 193 | Geauga Hospital | Chardon | Ohio | United States | 44024 |
| 194 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 195 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 196 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
| 197 | The Mark H Zangmeister Center | Columbus | Ohio | United States | 43219 |
| 198 | Mercy Cancer Center-Elyria | Elyria | Ohio | United States | 44035 |
| 199 | Mount Carmel Grove City Hospital | Grove City | Ohio | United States | 43123 |
| 200 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
| 201 | UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio | United States | 44130 |
| 202 | University Hospitals Parma Medical Center | Parma | Ohio | United States | 44129 |
| 203 | University Hospitals Portage Medical Center | Ravenna | Ohio | United States | 44266 |
| 204 | UH Seidman Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio | United States | 44870 |
| 205 | University Hospitals Sharon Health Center | Wadsworth | Ohio | United States | 44281 |
| 206 | Saint Ann's Hospital | Westerville | Ohio | United States | 43081 |
| 207 | UH Seidman Cancer Center at Saint John Medical Center | Westlake | Ohio | United States | 44145 |
| 208 | UHHS-Westlake Medical Center | Westlake | Ohio | United States | 44145 |
| 209 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 210 | Good Samaritan Hospital | Corvallis | Oregon | United States | 97330 |
| 211 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 212 | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | United States | 19010 |
| 213 | Carlisle Regional Cancer Center | Carlisle | Pennsylvania | United States | 17015 |
| 214 | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | United States | 19317 |
| 215 | UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | United States | 16505 |
| 216 | Saint Vincent Hospital | Erie | Pennsylvania | United States | 16544 |
| 217 | UPMC Cancer Center at UPMC Horizon | Farrell | Pennsylvania | United States | 16121 |
| 218 | UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg | Pennsylvania | United States | 15601 |
| 219 | UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg | Pennsylvania | United States | 17109 |
| 220 | Jefferson Hospital | Jefferson Hills | Pennsylvania | United States | 15025 |
| 221 | Lancaster General Ann B Barshinger Cancer Institute | Lancaster | Pennsylvania | United States | 17601 |
| 222 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17602 |
| 223 | UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion | Mechanicsburg | Pennsylvania | United States | 17050 |
| 224 | Riddle Memorial Hospital | Media | Pennsylvania | United States | 19063 |
| 225 | Forbes Hospital | Monroeville | Pennsylvania | United States | 15146 |
| 226 | UPMC Cancer Center - Monroeville | Monroeville | Pennsylvania | United States | 15146 |
| 227 | Bryn Mawr Health Center | Newtown Square | Pennsylvania | United States | 19073 |
| 228 | Paoli Memorial Hospital | Paoli | Pennsylvania | United States | 19301 |
| 229 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 230 | Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | United States | 19114 |
| 231 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 232 | UPMC-Magee Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 233 | UPMC-Saint Margaret | Pittsburgh | Pennsylvania | United States | 15215 |
| 234 | West Penn Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 235 | UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania | United States | 15232 |
| 236 | UPMC-Saint Clair Hospital Cancer Center | Pittsburgh | Pennsylvania | United States | 15243 |
| 237 | Penn State Health Saint Joseph Medical Center | Reading | Pennsylvania | United States | 19605 |
| 238 | UPMC Washington Hospital Radiation Oncology | Washington | Pennsylvania | United States | 15301 |
| 239 | Reading Hospital | West Reading | Pennsylvania | United States | 19611 |
| 240 | Wexford Health and Wellness Pavilion | Wexford | Pennsylvania | United States | 15090 |
| 241 | Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | United States | 19090 |
| 242 | Lankenau Medical Center | Wynnewood | Pennsylvania | United States | 19096 |
| 243 | UPMC Memorial | York | Pennsylvania | United States | 17408 |
| 244 | Women and Infants Hospital | Providence | Rhode Island | United States | 02905 |
| 245 | Kent Hospital | Warwick | Rhode Island | United States | 02886 |
| 246 | Saint Joseph's/Candler - Bluffton Campus | Bluffton | South Carolina | United States | 29910 |
| 247 | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | United States | 29316 |
| 248 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 249 | Prisma Health Cancer Institute - Faris | Greenville | South Carolina | United States | 29605 |
| 250 | Saint Francis Cancer Center | Greenville | South Carolina | United States | 29607 |
| 251 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
| 252 | Self Regional Healthcare | Greenwood | South Carolina | United States | 29646 |
| 253 | Prisma Health Cancer Institute - Greer | Greer | South Carolina | United States | 29650 |
| 254 | The Radiation Oncology Center-Hilton Head/Bluffton | Hilton Head Island | South Carolina | United States | 29926 |
| 255 | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | United States | 29672 |
| 256 | Lexington Medical Center | West Columbia | South Carolina | United States | 29169 |
| 257 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 258 | Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | United States | 38120 |
| 259 | MD Anderson in The Woodlands | Conroe | Texas | United States | 77384 |
| 260 | Parkland Memorial Hospital | Dallas | Texas | United States | 75235 |
| 261 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 262 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
| 263 | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | United States | 77030 |
| 264 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 265 | MD Anderson West Houston | Houston | Texas | United States | 77079 |
| 266 | Doctor's Hospital of Laredo | Laredo | Texas | United States | 78041 |
| 267 | MD Anderson League City | League City | Texas | United States | 77573 |
| 268 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
| 269 | MD Anderson in Sugar Land | Sugar Land | Texas | United States | 77478 |
| 270 | American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah | United States | 84003 |
| 271 | Sandra L Maxwell Cancer Center | Cedar City | Utah | United States | 84720 |
| 272 | Farmington Health Center | Farmington | Utah | United States | 84025 |
| 273 | Logan Regional Hospital | Logan | Utah | United States | 84321 |
| 274 | Intermountain Medical Center | Murray | Utah | United States | 84107 |
| 275 | McKay-Dee Hospital Center | Ogden | Utah | United States | 84403 |
| 276 | Utah Valley Regional Medical Center | Provo | Utah | United States | 84604 |
| 277 | Saint George Regional Medical Center | Saint George | Utah | United States | 84770 |
| 278 | University of Utah Sugarhouse Health Center | Salt Lake City | Utah | United States | 84106 |
| 279 | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | United States | 84112 |
| 280 | South Jordan Health Center | South Jordan | Utah | United States | 84009 |
| 281 | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont | United States | 05602 |
| 282 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 283 | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont | United States | 05819 |
| 284 | Augusta Health Center for Cancer and Blood Disorders | Fishersville | Virginia | United States | 22939 |
| 285 | MultiCare Auburn Medical Center | Auburn | Washington | United States | 98001 |
| 286 | MultiCare Gig Harbor Medical Park | Gig Harbor | Washington | United States | 98335 |
| 287 | MultiCare Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 288 | West Virginia University Healthcare | Morgantown | West Virginia | United States | 26506 |
| 289 | Langlade Hospital and Cancer Center | Antigo | Wisconsin | United States | 54409 |
| 290 | ThedaCare Regional Cancer Center | Appleton | Wisconsin | United States | 54911 |
| 291 | Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | United States | 54701 |
| 292 | Aurora Cancer Care-Grafton | Grafton | Wisconsin | United States | 53024 |
| 293 | Bellin Memorial Hospital | Green Bay | Wisconsin | United States | 54301 |
| 294 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 295 | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | United States | 54303 |
| 296 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 297 | UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin | United States | 53038 |
| 298 | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | United States | 53142 |
| 299 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 300 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53792 |
| 301 | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | United States | 54143 |
| 302 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
| 303 | Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | United States | 53051 |
| 304 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 305 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 306 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53233 |
| 307 | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | United States | 54548 |
| 308 | Cancer Center of Western Wisconsin | New Richmond | Wisconsin | United States | 54017 |
| 309 | Drexel Town Square Health Center | Oak Creek | Wisconsin | United States | 53154 |
| 310 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 311 | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | United States | 54868 |
| 312 | HSHS Saint Nicholas Hospital | Sheboygan | Wisconsin | United States | 53081 |
| 313 | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | United States | 53081 |
| 314 | Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | United States | 54482 |
| 315 | Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin | United States | 54235-1495 |
| 316 | Aurora Medical Center in Summit | Summit | Wisconsin | United States | 53066 |
| 317 | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | United States | 54241 |
| 318 | Aspirus Regional Cancer Center | Wausau | Wisconsin | United States | 54401 |
| 319 | Aurora West Allis Medical Center | West Allis | Wisconsin | United States | 53227 |
| 320 | Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | United States | 53095 |
| 321 | Diagnostic and Treatment Center | Weston | Wisconsin | United States | 54476 |
| 322 | Marshfield Medical Center - Weston | Weston | Wisconsin | United States | 54476 |
| 323 | Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | United States | 54494 |
| 324 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 325 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 326 | BCCA-Abbotsford Cancer Centre | Abbotsford | British Columbia | Canada | V2S 1K2 |
| 327 | BCCA-Cancer Centre for the Southern Interior | Kelowna | British Columbia | Canada | V1Y 5L3 |
| 328 | BCCA-Cancer Centre for the North | Prince George | British Columbia | Canada | V2M 7E9 |
| 329 | BCCA-Fraser Valley Cancer Centre | Surrey | British Columbia | Canada | V3V 1Z2 |
| 330 | BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 331 | BCCA-Vancouver Island Cancer Centre | Victoria | British Columbia | Canada | V8R 6V5 |
| 332 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 333 | Atlantic Health Sciences Corporation-Saint John Regional Hospital | Saint John | New Brunswick | Canada | E2L 4L2 |
| 334 | Doctor H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 335 | QEII Health Sciences Centre/Nova Scotia Health Authority | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 336 | Royal Victoria Regional Health Centre | Barrie | Ontario | Canada | L4M 6M2 |
| 337 | Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8V 5C2 |
| 338 | Kingston Health Sciences Centre | Kingston | Ontario | Canada | K7L 2V7 |
| 339 | Grand River Regional Cancer Centre at Grand River Hospital | Kitchener | Ontario | Canada | N2G 1G3 |
| 340 | London Regional Cancer Program | London | Ontario | Canada | N6A 4L6 |
| 341 | Trillium Health Partners - Credit Valley Hospital | Mississauga | Ontario | Canada | L5M 2N1 |
| 342 | Ottawa Hospital and Cancer Center-General Campus | Ottawa | Ontario | Canada | K1H 8L6 |
| 343 | Niagara Health System-Saint Catharines General | Saint Catharines | Ontario | Canada | L2S 0A9 |
| 344 | Algoma District Cancer Program Sault Area Hospital | Sault Ste Marie | Ontario | Canada | P6B 0A8 |
| 345 | Health Sciences North | Sudbury | Ontario | Canada | P3E 5J1 |
| 346 | Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 347 | University Health Network-Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 348 | CSSS Champlain-Charles Le Moyne | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 349 | Hopital de la Cite-de-la-Sante | Laval | Quebec | Canada | H7M 3L9 |
| 350 | CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal | Quebec | Canada | H1T 2M4 |
| 351 | CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2X 3E4 |
| 352 | The Research Institute of the McGill University Health Centre (MUHC) | Montreal | Quebec | Canada | H3H 2R9 |
| 353 | Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
| 354 | CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Quebec City | Quebec | Canada | G1R 2J6 |
| 355 | Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 356 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
| 357 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
Sponsors and Collaborators
- Canadian Cancer Trials Group
- Alliance for Clinical Trials in Oncology
- Eastern Cooperative Oncology Group
- NRG Oncology
- Southwest Oncology Group
Investigators
- Study Chair: Timothy Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, Ontario Canada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Canadian Cancer Trials Group
ClinicalTrials.gov Identifier:
NCT03488693
Other Study ID Numbers:
- CCTG MA.39
- NCI-2017-02047
First Posted:
Apr 5, 2018
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: