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



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

For Condition: stage 3 non-small cell lung cancer,stage 2 non-small cell lung cancer,stage 1 non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): London Lung Cancer Group ,
Synopsis: 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.
Details: OBJECTIVES: I. Assess whether the addition of cisplatin based chemotherapy to standard treatment improves survival in patients with non-small cell lung cancer. PROTOCOL OUTLINE: This is a randomized study in which patients receiving primary surgery, radical radiotherapy, radiotherapy with surgery, or supportive care are randomized to either arm I (that treatment alone) or arm II (the same treatment with chemotherapy). Chemotherapy begins within 10 weeks of surgery or radical radiotherapy, or as soon as possible after diagnosis. Patients randomized to arm II receive a total of 3 courses of one of the following regimens: Regimen A: Cisplatin IV on day 1 followed by vindesine on days 1 and 8 Regimen B: Mitomycin, ifosfamide, and cisplatin on day 1 Regimen C: Mitomycin, vinblastine, and cisplatin on day 1 Regimen D: Vinorelbine on days 1 and 8 and cisplatin on day 1 Each course is repeated every 3 weeks. Patients are followed at 3 months, 6 months, 1 year and annually thereafter. PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study within 3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven non-small cell lung cancer being treated with surgery, radical radiotherapy, surgery plus radiotherapy, or best supportive care --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Prior radical radiotherapy allowed - Surgery: Prior surgery allowed --Patient Characteristics-- - Age: Not specified - Performance Status: Not specified - Life Expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: No inadequate renal function - Other: No prior or concurrent malignancies within the past 3 years except nonmelanoma skin cancer; Must be fit enough to receive therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StephenSpiro,  Study Chair,  London Lung Cancer Group

Middlesex Hospital- Meyerstein Institute
London,  England,  WIT 3AA
United Kingdom
 


Additional Information:
Study ID Numbers:
  CDR0000066115;  LLCG-BLT,EU-98003,MRC-BLT
Study Start Date: October 1995
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003240

Other Stage 2 Non-Small Cell Lung Cancer Studies:
1. Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer

2. Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

3. Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer

4. Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer

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

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

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