A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.
- Small-cell lung cancer.
- Patients who, after (at least) a first line of chemotherapy based on platinum, had a
partial response and then progressed, or who had a complete response and then
relapsed within three months following the last course of this first-line therapy.
- Measurable or assessable disease.
- Life expectancy >2 months.
- Patients with a therapeutic risk level of <5 points (see section 6: "Treatment
- Age >18 years;
- Performance status (WHO) <2;
- One measurable target lesion in a non irradiated region;
- Prior radiotherapy authorized unless it targeted the only measurable lesion;
- Biological criteria: WBC >2000/mm3, PMN >1500/mm3, platelets >100 000/mm3,
creatinemia <2 x ULN, bilirubinemia
- normal ECG
- written informed consent.
- Non small-cell lung cancer.
- No objective response to platinum-based therapy
- Complete response lasting more than three months after the last course of first-line
- Symptomatic brain metastases.
- Bone metastases, carcinomatous lymphangitis, ascites or pleurisy as sole assessable
disease manifestations.- Concurrent participation in another clinical trial.
- Therapeutic risk level of 6 points or more (see table)
- Uncontrolled clotting disorders;
- Uncontrolled severe infection;
- History of another malignancy, except for cervical carcinoma in situ or basocellular
cancer that are considered cured;
- Psychological, familial, sociological or geographic circumstances preventing
treatment follow-up as defined in the protocol;
- Patients deprived of their rights for administrative or legal reasons.