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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Southwest Oncology Group Eastern Cooperative Oncology Group Cancer and Leukemia Group B North Central Cancer Treatment Group NCIC Clinical Trials Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002550 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or without surgery for lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin, etoposide, and radiation therapy with or without surgery in treating patients who have stage IIIA non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: etoposide Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A PHASE III COMPARISON BETWEEN CONCURRENT CHEMOTHERAPY PLUS RADIOTHERAPY AND CONCURRENT CHEMOTHERAPY PLUS RADIOTHERAPY FOLLOWED BY SURGICAL RESECTION FOR STAGE IIIA (N2) NON-SMALL CELL LUNG CANCER |
| Estimated Enrollment: | 510 |
| Study Start Date: | March 1994 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified by contralateral mediastinal sampling or biopsy (yes vs no), tumor stage (T1 vs T2 vs T3), and performance status (70-80% vs 90-100%). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 510 patients will be accrued for this study within 4.9 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven newly diagnosed, stage IIIA (T1-3, N2) non-small cell lung cancer
Eligible subtypes:
Measurable or evaluable disease on chest x-ray and/or contrast CT scan
Pleural effusions allowed if 1 of the following conditions is met:
Positive ipsilateral mediastinal node(s) with or without positive ipsilateral hilar nodes
Nodal biopsy or aspiration waived if all of the following conditions are met:
No positive nodes in contralateral mediastinum (supraclavicular areas and higher) and neck
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| United States, New York | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, Pennsylvania | |
| Hahnemann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Wisconsin | |
| CCOP - Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| South Africa | |
| Pretoria Academic Hospitals | |
| Pretoria, South Africa, 0001 | |
| Study Chair: | David S. Ettinger, MD | Sidney Kimmel Comprehensive Cancer Center |
| Study Chair: | Kathy S. Albain, MD | Loyola University |
| Study Chair: | David H. Johnson, MD | Vanderbilt-Ingram Cancer Center |
| Study Chair: | Bruce E. Johnson, MD | Dana-Farber Cancer Institute |
| Study Chair: | Mark R. Green, MD | Medical University of South Carolina |
| Study Chair: | Robert C. Miller, MD | Mayo Clinic |
| Study Chair: | Yvon Cormier, MD | L'Hopital Laval |
More Information
| ClinicalTrials.gov Identifier: | NCT00002550 History of Changes |
| Other Study ID Numbers: | CDR0000063333, RTOG-9309, CAN-NCIC-BR13, CLB-9592, E-R9309, NCCTG-R9309, NCI-94-C-0043, SWOG-9336, INT-0139 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 2, 2010 |
| Health Authority: | United States: Federal Government |
|
squamous cell lung cancer large cell lung cancer stage IIIA non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |