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Sponsored by: |
Allos Therapeutics |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055887 |
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. Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: efaproxiral Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: vinorelbine ditartrate Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) Non-Small Cell Lung Cancer |
Study Start Date: | November 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to chemotherapy regimen, Karnofsky performance status (70-80% vs 90-100%), and disease stage (IIIA vs IIIB).
Induction therapy phase: Patients receive 1 of the following induction chemotherapy regimens:
Randomized phase: Within 42 days after completion of chemotherapy, patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, on days 1 and 16 of radiotherapy, monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 659 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer of 1 of the following subtypes:
Stage IIIA or IIIB
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arizona | |
St. Joseph's Hospital and Medical Center | |
Phoenix, Arizona, United States, 85013 | |
United States, Idaho | |
North Idaho Cancer Center | |
Coeur d'Alene, Idaho, United States, 83814 | |
United States, Kentucky | |
Cancer Center at Lexington Clinic | |
Lexington, Kentucky, United States, 40504 | |
United States, Louisiana | |
Willis - Knighton Cancer Center | |
Shreveport, Louisiana, United States, 71103-3951 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
St. Agnes Cancer Center | |
Baltimore, Maryland, United States, 21229 | |
United States, Washington | |
Providence Everett Medical Center - Pacific Campus | |
Everett, Washington, United States, 98206 | |
United States, West Virginia | |
Schiffler Cancer Center | |
Wheeling, West Virginia, United States, 26003 | |
Belgium | |
Algemeen Ziekenhuis Middelheim | |
Antwerp, Belgium, 2020 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Tom Baker Cancer Center - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, Ontario | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Ottawa Regional Cancer Centre | |
Ottawa, Ontario, Canada, K1H 1C4 | |
Canada, Quebec | |
Centre Hospitalier Universitaire de Quebec | |
Quebec City, Quebec, Canada, G1R 2J6 | |
CHUS-Hopital Fleurimont | |
Fleurimont, Quebec, Canada, J1H 5N4 | |
Hopital Notre- Dame du CHUM | |
Montreal, Quebec, Canada, H2L 4M1 | |
Maisonneuve-Rosemont Hospital | |
Montreal, Quebec, Canada, H1T 2M4 | |
McGill University | |
Montreal, Quebec, Canada, H2W 1S6 | |
Israel | |
Rambam Medical Center | |
Haifa, Israel, 31096 | |
Sheba Medical Center | |
Tel Hashomer, Israel, 52621 | |
Soroka University Medical Center | |
Beer-Sheva, Israel, 84101 | |
Tel-Aviv Sourasky Medical Center | |
Tel-Aviv, Israel, 64239 |
Study Chair: | Hak Choy, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000271438, ALLOS-RSR13RT-013ELITE |
Study First Received: | March 6, 2003 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00055887 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IIIA non-small cell lung cancer adenocarcinoma of the lung squamous cell lung cancer large cell lung cancer |
Thoracic Neoplasms Antimetabolites Immunologic Factors Vinblastine Efaproxiral Respiratory Tract Diseases Cisplatin Lung Neoplasms Gemcitabine Carboplatin Antimitotic Agents Antiviral Agents Immunosuppressive Agents |
Carcinoma Vinorelbine Radiation-Sensitizing Agents Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Vinblastine Efaproxiral Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Gemcitabine Respiratory Tract Neoplasms Antisickling Agents Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Vinorelbine Radiation-Sensitizing Agents |