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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin; Vincristine

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