Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer

Launched by MEDICAL RESEARCH COUNCIL · Apr 15, 2003

Keywords

ClinConnect Summary

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 re...

Gender

ALL

Eligibility 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