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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003240
First Posted: February 20, 2004
Last Update Posted: December 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
November 1, 1999
February 20, 2004
December 18, 2013
October 1995
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Complete list of historical versions of study NCT00003240 on ClinicalTrials.gov Archive Site
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Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
A Major Randomised Trial to Determine the Value of Cisplatin-Based Chemotherapy For All Patients With Non-Small Cell Lung Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: ifosfamide
  • Drug: mitomycin C
  • Drug: vinblastine sulfate
  • Drug: vindesine
  • Drug: vinorelbine tartrate
  • Procedure: conventional surgery
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1800
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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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00003240
CDR0000066115
LLCG-BLT
MRC-BLT
EU-98003
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National Cancer Institute (NCI)
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Study Chair: Stephen G. Spiro University College London Hospitals
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP