Randomised controlled clinical trial of oral etoposide versus intravenous multi-drug chemotherapy in the palliative treatment of patients with Small-Cell Lung Cancer (SCLC) and a poor prognosis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2002
INTERVENTION: 1. Oral Etoposide Regimen (E): Four courses of oral etopsimide twice daily for ten days at three week intervals (i.e. ten days of chemotherapy in each three week period). 2. Intravenous Multi‐Drug Chemotherapy Regimen (EV or CAV): Clinicians chose to use one of two multi‐drug chemotherapy regimens: EV: Intravenous etoposide and vincristine four courses given at three week intervals, each course given over three days according to the protocol. CAV: Intravenous cyclophosphamide, doxorubicin and vincristine four courses given at three week intervals, each course given on one day. All treatments should start as soon as possible after randomisation. CONDITION: Small‐Cell Lung Cancer (SCLC) ; Cancer ; Lung Cancer PRIMARY OUTCOME: Not provided at time of registration. SECONDARY OUTCOME: Not provided at time of registration. INCLUSION CRITERIA: 1. Microscopically proven SCLC 2. Limited or extensive disease 3. World Health Organisation (WHO) performance status grade two, three or four 4. No previous chemotherapy, radiotherapy, or surgery for small‐cell lung cancer 5. No other previous or concomitant malignant disease, except basal cell carcinoma or in situ carcinoma of the cervix 6. No other serious condition contraindicating treatment with cytotoxic chemotherapy. Patients with evidence of liver cell damage are eligible 7. Renal function normal: plasma creatinine or urea concentration within normal limits 8. Plasma Billirubin less than 35 µmol/l 9. Any age, either sex
Epistemonikos ID: 5ae3fe1836b4f5a9b5d30b792faa83aafc6eacf3
First added on: Aug 21, 2024