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Sponsored by: |
University Hospital Birmingham |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112710 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 1350 |
Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 or 2), disease stage (IIIB vs IV), and participating center. Patients are randomized to 1 of 3 treatment arms.
In all arms, treatment repeats every 21 days for 2 courses. Patients are reassessed after 2 courses. Patients with responding disease or stable disease with symptom improvement receive 2 additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression or stable disease without symptom improvement are removed from the study.
Quality of life is assessed at baseline, on day 1 of courses 2-4, at completion of study treatment, and then monthly for 6 months.
After completion of study treatment, patients are followed monthly for 6 months and then periodically thereafter for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,350 patients (450 per treatment arm) will be accrued for this study within 6 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United Kingdom, England | |
Birmingham Heartlands Hospital | Recruiting |
Birmingham, England, United Kingdom, B9 5SS | |
Contact: Joyce Thompson 44-121-766-6611 | |
Institute of Clinical Research - Birmingham | Recruiting |
Birmingham, England, United Kingdom, B15 2TT | |
Contact: Hugh Jarrett 44-121-414-6425 |
Study Chair: | Hugh Jarrett | Institute of Clinical Research - Birmingham |
Study ID Numbers: | CDR0000429610, CRUK-BTOG2-LU3005, EU-20510 |
Study First Received: | June 2, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00112710 |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Carboplatin Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |