RANDOMISED CLINICAL TRIAL OF IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE WITH MID-CYCLE VINCRISTINE (VICE) VERSUS STANDARD PRACTICE CHEMOTHERAPY IN PATIENTS WITH LIMITED STAGE SMALL CELL LUNG CANCER (SCLC) AND GOOD PERFORMANCE STATUS
carboplatin
+ cisplatin
+ cyclophosphamide
Lung Diseases+4
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: March 1, 1996
Actual date on which the first participant was enrolled.OBJECTIVES: Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy. Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients. Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments. OUTLINE: This is a randomized study. The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses. The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses. Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy. Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option. Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter. PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Microscopically proven small cell lung cancer Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology No pleural fluid cytology No prior therapy PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Hematopoietic: WBC more than 3,000 ANC more than 1,500 Platelets more than 100,000 Hepatic/Renal: Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal Creatinine or urea normal Creatinine clearance or GFR more than 65 mL/min Other: No clinical evidence of infection No prior or concurrent malignancy that interferes with protocol treatments or comparisons No other condition that contraindicates treatment Willing and able to complete quality-of-life questionnaires Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Medical Research Council Clinical Trials Unit
London, United KingdomOpen Medical Research Council Clinical Trials Unit in Google Maps