|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group American College of Surgeons North Central Cancer Treatment Group NCIC Clinical Trials Group Cancer and Leukemia Group B |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062439 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: docetaxel Drug: etoposide Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | 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) |
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2003 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
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.
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Any of the following stages due to involvement of the superior sulcus:
Must meet 1 of the following tumor involvement criteria:
No involvement of the following lymph node groups as determined by mediastinal exploration* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy) within the past 42 days:
Supraclavicular (scalene) nodes
No pleural effusions except if 1 of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Zubrod 0-2
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36652-2144 | |
| United States, Colorado | |
| Poudre Valley Hospital | |
| Fort Collins, Colorado, United States, 80524 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Regional Cancer Center at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781-0001 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| United States, Kansas | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| United States, Michigan | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49442 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| Butterworth Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Community Cancer Center of Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Foote Memorial Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49001 | |
| Haematology-Oncology Associates of Ohio and Michigan, PC | |
| Lambertville, Michigan, United States, 48144 | |
| Hickman Cancer Center at Bixby Medical Center | |
| Adrian, Michigan, United States, 49221 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Lacks Cancer Center at Saint Mary's Health Care | |
| Grand Rapids, Michigan, United States, 49503 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Mercy Memorial Hospital - Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Metro Health Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Mecosta County Medical Center | |
| Big Rapids, Michigan, United States, 49307 | |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | |
| Southfield, Michigan, United States, 48075 | |
| Saint Joseph Mercy Cancer Center | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Seton Cancer Institute at Saint Mary's - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48912-1811 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Duluth Clinic Cancer Center - Duluth | |
| Duluth, Minnesota, United States, 55805-1983 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Miller - Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Willmar Cancer Center at Rice Memorial Hospital | |
| Willmar, Minnesota, United States, 56201 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Arch Medical Services, Incorporated at Center for Cancer Care and Research | |
| Saint Louis, Missouri, United States, 63141 | |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
| Columbia, Missouri, United States, 65201 | |
| Missouri Baptist Cancer Center | |
| St. Louis, Missouri, United States, 63131 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| United States, Montana | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405-5309 | |
| Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| Bozeman Deaconess Cancer Center | |
| Bozeman, Montana, United States, 59715 | |
| Great Falls, Montana, United States, 59405 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Great Falls Clinic - Main Facility | |
| Great Falls, Montana, United States, 59405 | |
| Guardian Oncology and Center for Wellness | |
| Missoula, Montana, United States, 59804 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Kalispell Medical Oncology at KRMC | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59807 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59807-7877 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| Sletten Cancer Institute at Benefis Healthcare | |
| Great Falls, Montana, United States, 59405 | |
| St. James Healthcare Cancer Care | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| St. Vincent Healthcare Cancer Care Services | |
| Billings, Montana, United States, 59101 | |
| United States, North Carolina | |
| Kinston Medical Specialists | |
| Kinston, North Carolina, United States, 28501 | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| United States, North Dakota | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501 | |
| Medcenter One Hospital Cancer Care Center | |
| Bismarck, North Dakota, United States, 58501 | |
| Mid Dakota Clinic, PC | |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Medical Center Cancer Center | |
| Bismarck, North Dakota, United States, 58502 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| Fremont Memorial Hospital | |
| Fremont, Ohio, United States, 43420 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267 | |
| Firelands Regional Medical Center | |
| Sandusky, Ohio, United States, 44870 | |
| Flower Hospital Cancer Center | |
| Sylvania, Ohio, United States, 43560 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43617 | |
| Fulton County Health Center | |
| Wauseon, Ohio, United States, 43567 | |
| Lima Memorial Hospital | |
| Lima, Ohio, United States, 45804 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Mercy Hospital of Tiffin | |
| Tiffin, Ohio, United States, 44883 | |
| North Coast Cancer Care, Incorporated | |
| Sandusky, Ohio, United States, 44870 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| St. Charles Mercy Hospital | |
| Oregon, Ohio, United States, 43616 | |
| St. Luke's Hospital | |
| Maumee, Ohio, United States, 43537 | |
| St. Rita's Medical Center | |
| Lima, Ohio, United States, 45801 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43537 | |
| Toledo Clinic - Oregon | |
| Oregon, Ohio, United States, 43616 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Wood County Oncology Center | |
| Bowling Green, Ohio, United States, 43402 | |
| United States, Oregon | |
| Northwest Cancer Specialists at Rose Quarter Cancer Center | |
| Portland, Oregon, United States, 97227 | |
| United States, South Carolina | |
| AnMed Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| MBCCOP - Meharry Medical College - Nashville | |
| Nashville, Tennessee, United States, 37208-3599 | |
| United States, Utah | |
| American Fork Hospital | |
| American Fork, Utah, United States, 84003 | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center - East Campus | |
| Saint George, Utah, United States, 84770 | |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | |
| Murray, Utah, United States, 84157 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84103 | |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| Sandra L. Maxwell Cancer Center | |
| Cedar City, Utah, United States, 84720 | |
| Utah Cancer Specialists at UCS Cancer Center | |
| Salt Lake City, Utah, United States, 84106 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| Logan Regional Hospital | |
| Logan, Utah, United States, 84321 | |
| United States, Virginia | |
| Fredericksburg Oncology, Incorporated | |
| Fredericksburg, Virginia, United States, 22401 | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Allenmore Hospital | |
| Tacoma, Washington, United States, 98405 | |
| Auburn Regional Center for Cancer Care | |
| Auburn, Washington, United States, 98002 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Columbia Basin Hematology | |
| Kennewick, Washington, United States, 99336 | |
| Franciscan Cancer Center at St. Joseph Medical Center | |
| Tacoma, Washington, United States, 98405-3004 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405 | |
| Good Samaritan Cancer Center | |
| Puyallup, Washington, United States, 98372 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98112 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Minor and James Medical, PLLC | |
| Seattle, Washington, United States, 98104 | |
| MultiCare Regional Cancer Center at Tacoma General Hospital | |
| Tacoma, Washington, United States, 98405 | |
| Providence St. Peter Hospital Regional Cancer Center | |
| Olympia, Washington, United States, 98506-5166 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Polyclinic First Hill | |
| Seattle, Washington, United States, 98122 | |
| Providence Centralia Hospital | |
| Centralia, Washington, United States, 98531-9027 | |
| Northwest Cancer Specialists at Vancouver Cancer Center | |
| Vancouver, Washington, United States, 98684 | |
| St. Clare Hospital | |
| Tacoma, Washington, United States, 98499 | |
| St. Francis Hospital | |
| Federal Way, Washington, United States, 98003 | |
| St. Joseph Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98122-4307 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Wenatchee Valley Medical Center | |
| Wenatchee, Washington, United States, 98801-2028 | |
| United States, West Virginia | |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | |
| Parkersburg, West Virginia, United States, 26102 | |
| United States, Wisconsin | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| United States, Wyoming | |
| Welch Cancer Center at Sheridan Memorial Hospital | |
| Sheridan, Wyoming, United States, 82801 | |
| Study Chair: | Michael J. Kraut, MD | Providence Cancer Institute at Providence Hospital - Southfield Campus |
| Study Chair: | Tien Hoang, MD | University of Wisconsin, Madison |
| Study Chair: | Valerie W. Rusch, MD, FACS | Memorial Sloan-Kettering Cancer Center |
| Study Chair: | James R. Jett, MD | Mayo Clinic |
| Study Chair: | Scott A. Laurie, MD, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
| Study Chair: | Alan P. Lyss, MD | Missouri Baptist Cancer Center |
More Information
| Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
| Study ID Numbers: | CDR0000304777, SWOG-S0220, ECOG-S0220, ACOSOG-SWOG-S0220, NCCTG-SWOG-S0220, CAN-NCIC-SWOG-S0220, CALGB-30501 |
| Study First Received: | June 5, 2003 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00062439 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pancoast's Syndrome Etoposide phosphate Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Antineoplastic Agents, Phytogenic Etoposide Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |