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Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: December 17, 2013
Last verified: May 2007

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 sulfate
Drug: vindesine
Drug: vinorelbine tartrate
Procedure: conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Major Randomised Trial to Determine the Value of Cisplatin-Based Chemotherapy For All Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1800
Study Start Date: October 1995
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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Please refer to this study by its identifier: NCT00003240

United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, WIT 3AA
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Stephen G. Spiro University College London Hospitals
  More Information

Fairlamb DJ, Gower N, Milroy R, et al.: The Big Lung Trial (BLT): determining the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer (NSCLC). Preliminary results in the radical radiotherapy setting. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2570, 639, 2003.
Waller D, Fairlamb DJ, Gower N, et al.: The Big Lung Trial (BLT): determining the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer (NSCLC). Preliminary results in the surgical setting. [Abstract] Proceedings of the American Society of Clinical Oncology 22 : A-2543, 632, 2003.
Stephens RJ, Gower NH, Spiro SG, et al.: The Big Lung Trial (BLT): a major randomised trial to determine the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer. [Abstract] Lung Cancer 29 (1 Suppl 1): A-61, 20, 2000.
Pignon JP, Tribodet H, Scagliotti GV, et al.: Lung Adjuvant Cisplatin Evaluation (LACE): a pooled analysis of five randomized clinical trials including 4,584 patients. [Abstract] J Clin Oncol 24 (Suppl 18): A-7008, 2006. Identifier: NCT00003240     History of Changes
Other Study ID Numbers: CDR0000066115
Study First Received: November 1, 1999
Last Updated: December 17, 2013

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Alkylating processed this record on April 26, 2017