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
N/A
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
David J. Girling, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medical Research Council
Authority:
United States: Federal Government
Study ID:
CDR0000064998
NCT ID:
NCT00002822
Start Date:
March 1996
Completion Date:
Related Keywords:
- Lung Cancer
- limited stage small cell lung cancer
- extensive stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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