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| Sponsored by: |
London Lung Cancer Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003240 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether giving chemotherapy in addition to standard therapy is a more effective treatment for lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy given with or without combination chemotherapy in treating patients with non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: ifosfamide Drug: mitomycin C Drug: vinblastine Drug: vindesine Drug: vinorelbine ditartrate Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Major Randomised Trial to Determine the Value of Cisplatin-Based Chemotherapy For All Patients With Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 1800 |
| Study Start Date: | October 1995 |
OBJECTIVES: I. Assess whether the addition of cisplatin-based chemotherapy to standard treatment improves survival in patients with non-small cell lung cancer.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo primary surgery, radical radiotherapy, radiotherapy with surgery, or best supportive care. Arm II: Patients undergo treatment as in arm I. Beginning within 10 weeks after surgery or radical radiotherapy or as soon as possible after diagnosis, patients receive 1 of the following regimens: Regimen A: Patients receive cisplatin IV on day 1 followed by vindesine on days 1 and 8. Regimen B: Patients receive mitomycin, ifosfamide, and cisplatin on day 1. Regimen C: Patients receive mitomycin, vinblastine, and cisplatin on day 1. Regimen D: Patients receive vinorelbine on days 1 and 8 and cisplatin on day 1. Treatment in all 4 regimens repeats every 3 weeks for 3 courses. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer being treated with primary surgery, radical radiotherapy, surgery plus radiotherapy, or best supportive care
PATIENT CHARACTERISTICS: Age: Adult Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No inadequate renal function Other: No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer Must be fit enough to receive therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radical radiotherapy allowed Surgery: See Disease Characteristics Prior surgery allowed
Contacts and Locations| United Kingdom, England | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, WIT 3AA | |
| Study Chair: | Stephen G. Spiro | University College London Hospitals |
More Information
| Study ID Numbers: | CDR0000066115, LLCG-BLT, MRC-BLT, EU-98003 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003240 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Thoracic Neoplasms Vindesine Vinblastine Antimitotic Agents Mitomycins Carcinoma Anti-Bacterial Agents Ifosfamide Vinorelbine Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Tubulin Modulators Mitomycin Non-small Cell Lung Cancer Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Isophosphamide mustard |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Antibiotics, Antineoplastic Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Mitomycin Alkylating Agents Nucleic Acid Synthesis Inhibitors Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Pharmacologic Actions Carcinoma Ifosfamide Neoplasms Vinorelbine Radiation-Sensitizing Agents Lung Diseases Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung |
