S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
- Conditions
- Lung Cancer
- Interventions
- Procedure: conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00062439
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, 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. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Determine the feasibility of administering induction chemoradiotherapy comprising cisplatin and etoposide followed by surgical resection and adjuvant docetaxel in patients with non-small cell lung cancer involving the superior sulcus (Pancoast tumors).
* Determine overall survival of patients treated with this regimen.
* Determine time to progression in patients treated with this regimen.
* Determine confirmed and unconfirmed and complete and partial response during induction in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE:
* Induction chemoradiotherapy: Patients receive etoposide IV over 1 hour on days 1-5 and 29-33 and cisplatin IV over 1 hour on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy once daily 5 days a week for 5 weeks.
Within 2-4 weeks after completion of induction chemoradiotherapy, patients undergo disease evaluation. Patients with no evidence of local or overall disease progression undergo a thoracotomy within 3-7 weeks. Patients who do not qualify for surgery proceed to consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete.
* Consolidation chemotherapy: Within 3-8 weeks after thoracotomy, patients with no evidence of disease progression receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel cisplatin - Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel docetaxel - Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel etoposide - Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel conventional surgery - Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel radiation therapy -
- Primary Outcome Measures
Name Time Method Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel. After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.
- Secondary Outcome Measures
Name Time Method Response After completion of induction therapy. Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a \>= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.
Adverse Events Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Overall Survival daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter. The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
Progression-Free Survival at 3 Years At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment. Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.
Trial Locations
- Locations (153)
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
🇺🇸Southfield, Michigan, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
MBCCOP - Meharry Medical College - Nashville
🇺🇸Nashville, Tennessee, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Willmar Cancer Center at Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸St. Louis, Missouri, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Northwest Cancer Specialists at Rose Quarter Cancer Center
🇺🇸Portland, Oregon, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Auburn Regional Center for Cancer Care
🇺🇸Auburn, Washington, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Providence Centralia Hospital
🇺🇸Centralia, Washington, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
Franciscan Cancer Center at St. Joseph Medical Center
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
Northwest Cancer Specialists at Vancouver Cancer Center
🇺🇸Vancouver, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States