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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014196 |
Purpose
RATIONALE: Drugs used in chemotherapy 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 chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: docetaxel Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer |
| Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.
At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IIIB non-small cell lung cancer
Pathologically or radiographically documented positive N3 nodes
T4 tumor invading any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
One of the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| Veterans Affairs Medical Center - Tucson | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Veterans Affairs Medical Center - Little Rock (McClellan) | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| University of California Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Veterans Affairs Medical Center - West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, District of Columbia | |
| MBCCOP-Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Dwight David Eisenhower Army Medical Center | |
| Fort Gordon, Georgia, United States, 30905-5650 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813-2424 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859-5000 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | |
| Hines, Illinois, United States, 60141 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40502-2236 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0912 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| CCOP - Grand Rapids Clinical Oncology Program | |
| Grand Rapids, Michigan, United States, 49503 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Providence Hospital - Southfield | |
| Southfield, Michigan, United States, 48075-9975 | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| Veterans Affairs Medical Center - Ann Arbor | |
| Ann Arbor, Michigan, United States, 48105 | |
| Veterans Affairs Medical Center - Detroit | |
| Detroit, Michigan, United States, 48201-1932 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| Veterans Affairs Medical Center - Jackson | |
| Jackson, Mississippi, United States, 39216 | |
| Veterans Affairs Medical Center - Biloxi | |
| Biloxi, Mississippi, United States, 39531-2410 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5138 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Veterans Affairs Medical Center - Albany | |
| Albany, New York, United States, 12208 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| United States, Ohio | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| Veterans Affairs Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45220-2288 | |
| Barrett Cancer Center, The University Hospital | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| United States, Oklahoma | |
| Oklahoma Medical Research Foundation | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Veterans Affairs Medical Center - Oklahoma City | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97225 | |
| OHSU Cancer Institute | |
| Portland, Oregon, United States, 97239 | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97207 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| Veterans Affairs Medical Center - Charleston | |
| Charleston, South Carolina, United States, 29401-5799 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7845 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0565 | |
| Veterans Affairs Medical Center - Houston | |
| Houston, Texas, United States, 77030 | |
| Veterans Affairs Medical Center - San Antonio (Murphy) | |
| San Antonio, Texas, United States, 78284 | |
| Veterans Affairs Medical Center - Temple | |
| Temple, Texas, United States, 76504 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112-5550 | |
| Veterans Affairs Medical Center - Salt Lake City | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-5000 | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
| Veterans Affairs Medical Center - Seattle | |
| Seattle, Washington, United States, 98108 | |
| Study Chair: | Raja Mudad, MD, FACP | Tulane University Health Sciences Center |
More Information
| Study ID Numbers: | CDR0000068516, SWOG-S0022 |
| Study First Received: | April 10, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00014196 History of Changes |
| Health Authority: | United States: Federal Government |
|
squamous cell lung cancer large cell lung cancer stage IIIB non-small cell lung cancer adenocarcinoma of the lung |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |