A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- To compare the overall survival of patients with newly diagnosed, unresectable stage
IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose
conformal radiotherapy with concurrent and consolidation chemotherapy comprising
carboplatin and paclitaxel.
- To compare the overall survival of patients treated with versus without cetuximab in
the setting of concurrent chemotherapy
Secondary
- To compare progression-free survival and local-regional tumor control in patients
treated with these regimens.
- To compare the toxicity of high- versus standard-dose conformal radiotherapy and
concurrent chemotherapy with versus without cetuximab in these patients.
- To investigate the prognostic and predictive effects of gross tumor volume on overall
survival of patients treated with these regimens.
- To compare the quality of life of patients treated with these regimens.
- To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with
biological parameters.
- To analyze the predictive value of pre-treatment standardized uptake value (SUV) of PET
scan in predicting survival, distant metastasis, and local-regional control in patients
treated with these regimens.
- To explore biological markers to predict clinical outcome including survival, distant
metastasis, local-regional control, and QOL (including toxicity) in patients treated
with these regimens.
- To prospectively collect and bank tissue, blood, and urine specimens for future
biomarker analyses in predicting clinical outcome in patients treated with these
regimens.
- To investigate associations between epidermal growth factor receptor (EGFR) expression
and toxicity, response, overall survival, and progression-free survival.
OUTLINE: This is a multicenter study. Patients are stratified according to PET staging (yes
vs no), radiotherapy technique (3-dimensional conformal radiotherapy vs intensity-modulated
radiotherapy), Zubrod performance status (0 vs 1), 4-dimensional CT planning utilization
(yes vs no), and histology (squamous vs non-squamous). Patients are randomized to 1 of 4
treatment arms. (Arms II and IV closed to accrual effective 6/17/11)
- Arm I: Patients undergo standard dose radiotherapy 5 days a week for 6 weeks for a
total of 60 Gy. Patients receive concurrent chemotherapy comprising paclitaxel IV over
1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients
also receive consolidation treatment of paclitaxel and carboplatin on days 64 and 85.
Treatment repeats in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo high-dose radiotherapy 5 days per week for 7.5 weeks. Patient
also receive concurrent paclitaxel and carboplatin as in Arm I on days 1, 8, 15, 22,
29, 36, and 43 . Patients also receive consolidation treatment comprising paclitaxel
and carboplatin on days 71 and 92. (closed to accrual effective 6/17/11)
- Arm III: Patients undergo standard-dose radiotherapy 5 days a week for 6 weeks for a
total of 60 Gy. Patients receive cetuximab in addition to concurrent chemotherapy as in
Arm I. Treatment continues with chemoradiation and cetuximab on days 8, 15, 22, 29, 36,
and 43. Patients receive consolidation treatment of cetuximab on days 50, 57, 64, 71,
78, 85, 92, 99, and 106 and paclitaxel and carboplatin on days 71 and 92.
- Arm IV: Patients undergo high-dose radiotherapy 5 days a week for 7.5 weeks for a total
of 74 Gy. Patients receive cetuximab in addition to concurrent chemotherapy as in Arm
I. Treatment continues with chemoradiation and cetuximab on days 8, 15, 22, 29, 36, 43,
and 50. Patients receive consolidation treatment of cetuximab on days 57, 64, 71, 78,
85, 92, 99, 106, and 113 and paclitaxel and carboplatin on days 78 and 99. (closed to
accrual effective 6/17/11) Patients may undergo tumor tissue, blood, and urine
collection periodically during study for tissue banking or biomarker correlative
studies.
Patients may undergo quality-of-life assessment at baseline and periodically during study.
After completion of study therapy, patients are followed periodically for 5 years and then
annually thereafter.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall (Failure: death from any cause) survival
From randomization to date of death or last follow-up. Analysis occurs after 339 deaths have been reported.
No
Jeffrey Bradley, MD
Principal Investigator
Mallinckrodt Institute of Radiology at Washington University Medical Center
United States: Food and Drug Administration
RTOG 0617
NCT00533949
November 2007
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
Swedish Medical Center | Englewood, Colorado 80110 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Harrington Cancer Center | Amarillo, Texas 79106 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Bellin Memorial Hospital | Green Bay, Wisconsin 54301 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
UMDNJ University Hospital | Newark, New Jersey 07103 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
Broward General Medical Center Cancer Center | Ft. Lauderdale, Florida 33316 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York, New York 10027 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Piedmont Hospital | Atlanta, Georgia 30309 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Community Cancer Center | Normal, Illinois 61761 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Highland Hospital of Rochester | Rochester, New York 14620 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Poudre Valley Radiation Oncology | Fort Collins, Colorado 80528 |
Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Midelfort Clinic - Luther | Eau Claire, Wisconsin 54702 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Stanford Cancer Center | Stanford, California 94305-5824 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
St. Joseph Hospital Regional Cancer Center - Orange | Orange, California 92868-3849 |
Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Regional Cancer Center - Erie | Erie, Pennsylvania 16505 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Baptist Medical Center South | Jascksonville, Florida 32258 |
Florida Cancer Center - Palatka | Palatka, Florida 32177 |
Flagler Cancer Center | Saint Augustine, Florida 32086 |
Tyler Cancer Center | Tyler, Texas 75702 |
Memorial Medical Center | Modesto, California 95355 |
Center for Cancer Care at Exeter Hospital | Exeter, New Hampshire 03833 |
Trinity CancerCare Center | Minot, North Dakota 58701 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Saint Mary's Regional Medical Center | Reno, Nevada 89503 |
Cancer Centers of North Carolina - Raleigh | Raleigh, North Carolina 27607 |
Integrated Community Oncology Network - Orange Park | Orange Park, Florida 32073 |
Alamance Cancer Center at Alamance Regional Medical Center | Burlington, North Carolina 27216 |
Luther Midlelfort Hospital | Eau Claire, Wisconsin 54702 |
Frankford Hospital Cancer Center - Torresdale Campus | Philadelphia, Pennsylvania 19114 |
Cancer Care Center at John Muir Health - Concord Campus | Concord, California 94524-4110 |
Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta, Georgia 30303 |
Shore Regional Cancer Center at Memorial Hospital - Easton | Easton, Maryland 21601 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
West Texas Cancer Center | Odessa, Texas 79761 |
Emory Crawford Long Hospital | Atlanta, Georgia 30308 |
New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany, New York 12208 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Barnes-Jewish West County Hospital | Saint Louis, Missouri 63141 |
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | Saint Peters, Missouri 63376 |
Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
Sands Cancer Center | Canandiaqua, New York 14424 |
University Radiation Oncology at Parkridge Hospital | Rochester, New York 14626 |
Community Regional Cancer Care at Community Hospital North | Indianapolis, Indiana 46256 |
Community Regional Cancer Care at Community Hospital East | Indianapolis, Indiana 46219 |
Integrated Community Oncology Network at Southside Cancer Center | Jacksonville, Florida 32207 |
Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
Longview Cancer Center | Longview, Texas 75601 |
Riverview UW Cancer Center at Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Saint Helena Hospital | Saint Helena, California 94574 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
Feather River Hospital Cancer Center | Paradise, California 95969 |
Radiation Oncology Associates Southwest | Fort Wayne, Indiana 46804 |
Central Indiana Cancer Centers - East | Indianapolis, Indiana 46219 |
Payson Center for Cancer Care at Concord Hospital | Concord, New Hampshire 03301 |
Willamette Valley Cancer Center - Eugene | Eugene, Oregon 97401 |
Texas Oncology, PA at Harris Center HEB | Bedford, Texas 76022 |
Texas Oncology, PA at Texas Cancer Center - Denton South | Denton, Texas 76210 |
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth, Texas 76104 |
Cancer Care Centers of South Texas - Northeast | San Antonio, Texas 78217 |
Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman, Texas 75090 |
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land, Texas 77479 |
Arizona Oncology - Tucson | Tucson, Arizona 85704 |
Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay, Wisconsin 54235-1495 |
Saint Agnes Cancer Center at Saint Agnes Medical Center | Fresno, California 93720 |
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center | Lincoln, Nebraska 68510 |
Texas Oncology, PA at Texas Cancer Center - Arlington South | Arlington, Texas 76014 |
D.N. Greenwald Center | Mukwonago, Wisconsin 53149 |