Informations générales (source: ClinicalTrials.gov)
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.
Observational
Groupe Francais De Pneumo-Cancerologie (Voir sur ClinicalTrials)
décembre 2005
mai 2010
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Saint Antoine | Christos CHOUAID, Professor | Contact (sur clinicalTrials) | |||
| HOPITAL NOVO | Gislaine FRABOULET, Doctor | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - 14000 - Caen - France | Radj GERVAIS, Doctor | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Les Oudairies - 85000 - La Roche Sur Yon - France | Acya BIZIEUX-TAMINY, Doctor | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire - 49033 - Angers - France | Thierry URBAN, Doctor | Contact (sur clinicalTrials) | |||
| Hôpital Yves Le Foll - 22023 - Saint Brieuc - France | Gwenaelle LE GARFF, Doctor | Contact (sur clinicalTrials) | |||
| Hospital du Cluzeau - 87042 - Limoges - France | Alain VERGNENEGRE, Professor | Contact (sur clinicalTrials) | |||
| Site 05 - 20200 - Bastia - France | Jean Cl MOURIES, Doctor | Contact (sur clinicalTrials) | |||
| Site 11 - 69655 - Villefranche Sur Saone - France | Lionel FALCHERO, Doctor | Contact (sur clinicalTrials) | |||
| Site 14 - 83800 - Toulon - France | Henri BERARD, Doctor | Contact (sur clinicalTrials) | |||
| Site 27 - 13695 - Martigues - France | Hervé JULLIAN, Doctor | Contact (sur clinicalTrials) | |||
| Site 43 - 14000 - Caen - France | Radj GERVAIS, Professor | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier du Morvan - 29200 - Brest - France | Gilles ROBINET, Doctor | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Lyon Sud - 69495 - Lyon - France | Laurence GERINIERE, Doctor | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Régional - 91160 - Longjumeau - France | Gérard OLIVIERO, Doctor | Contact (sur clinicalTrials) | |||
| Site 01 - 77108 - Meaux - France | Francois BLANCHON, Doctor | Contact (sur clinicalTrials) | |||
| Site 04 - 05000 - GAP - France | Pascal THOMAS, Doctor | Contact (sur clinicalTrials) | |||
| Site 06 - 13274 - Marseille - France | Fabrice BARLESI, Doctor | Contact (sur clinicalTrials) | |||
| Site 07 - 83300 - Draguignan - France | Hervé LECAER, Doctor | Contact (sur clinicalTrials) | |||
| Site 17 - 76233 - Rouen - France | Dominique PAILLOTIN, DOCTOR | Contact (sur clinicalTrials) | |||
| Site 22 - 60021 - Beauvais - France | Eric BOUCHAERT, Doctor | Contact (sur clinicalTrials) | |||
| Site 25 - 78200 - Mantes La Jolie - France | Jean B AULIAC, Doctor | Contact (sur clinicalTrials) | |||
| Site 32 - 76503 - Elbeuf - France | Philippe DAVID | Contact (sur clinicalTrials) | |||
| Site 33 - 94010 - Creteil - France | Isabelle MONNET, Doctor | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.