Clinical trial · Observational
Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)
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.
NCT00418743CI-TRIAL-00003243unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 flowchart"). * 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 \<ULN, ALT and AST \<2.5 x ULN (\< 5 N if liver metastases) * normal ECG * written informed consent. Exclusion Criteria: * 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 treatment. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.