A Phase II Trial of Induction Chemoradiotherapy With Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)
OBJECTIVES:
- Determine the feasbility 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Measurability of lesions
No
Michael J. Kraut, MD
Study Chair
Providence Cancer Institute at Providence Hospital - Southfield Campus
United States: Federal Government
CDR0000304777
NCT00062439
July 2003
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
| St. Rita's Medical Center | Lima, Ohio 45801 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Toledo Hospital | Toledo, Ohio 43606 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
| Holland Community Hospital | Holland, Michigan 49423 |
| Hackley Hospital | Muskegon, Michigan 49443 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| Big Sky Oncology | Great Falls, Montana 59405 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| American Fork Hospital | American Fork, Utah 84003 |
| Logan Regional Hospital | Logan, Utah 84321 |
| Cottonwood Hospital Medical Center | Murray, Utah 84107 |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
| Poudre Valley Hospital | Fort Collins, Colorado 80524 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| Community Cancer Center of Monroe | Monroe, Michigan 48162 |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
| Bismarck Cancer Center | Bismarck, North Dakota 58501 |
| Wood County Oncology Center | Bowling Green, Ohio 43402 |
| Fremont Memorial Hospital | Fremont, Ohio 43420 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| St. Luke's Hospital | Maumee, Ohio 43537 |
| Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
| Toledo Clinic - Oregon | Oregon, Ohio 43616 |
| St. Charles Mercy Hospital | Oregon, Ohio 43616 |
| North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
| Firelands Regional Medical Center | Sandusky, Ohio 44870 |
| Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Polyclinic First Hill | Seattle, Washington 98122 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| St. Francis Hospital | Federal Way, Washington 98003 |
| St. Clare Hospital | Lakewood, Washington 98499-0998 |
| Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
| Good Samaritan Cancer Center | Puyallup, Washington 98371 |
| Allenmore Hospital | Tacoma, Washington 98411-0414 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
| Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
| Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis, Missouri 63141 |
| Billings Clinic - Downtown | Billings, Montana 59107-7000 |
| Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
| St. James Healthcare Cancer Care | Butte, Montana 59701 |
| Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
| Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
| Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
| Northwest Cancer Specialists at Rose Quarter Cancer Center | Portland, Oregon 97227 |
| Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Providence Centralia Hospital | Centralia, Washington 98531-9027 |
| Columbia Basin Hematology | Kennewick, Washington 99336 |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
| Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Kinston Medical Specialists | Kinston, North Carolina 28501 |
| MBCCOP - Meharry Medical College - Nashville | Nashville, Tennessee 37208-3599 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Metro Health Hospital | Grand Rapids, Michigan 49506 |
| Great Falls, Montana 59405 | |
| Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
| St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
| AnMed Cancer Center | Anderson, South Carolina 29621 |
| Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
| St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
| Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |