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Non-Small Cell Lung Cancer |
Lung Cancer, Non-Small Cell |
Clinical Trial: Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
This study is no longer recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| stage III non-small cell lung cancer stage IV non-small cell lung cancer stage II non-small cell lung cancer stage I non-small cell lung cancer | Drug: cisplatin Drug: ifosfamide Drug: mitomycin Drug: vinblastine Drug: vindesine Drug: vinorelbine | Phase III |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Cisplatin Based Chemotherapy in Patients with Non-Small Cell Lung Cancer
Study start: 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.
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
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
Location Information
United Kingdom, England
Middlesex Hospital- Meyerstein Institute, London, England, WIT 3AA, United Kingdom
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003240
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Lung Cancer, Non-Small Cell (National Cancer Institute)
- Non-Small Cell Lung Cancer Treatment (National Cancer Institute)
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