Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)
Conditions
Small Cell Lung Cancer
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Conditions: Keywords
cancer, Lung cancer, small-cell lung cancer
Study Type
Observational
Study Phase
Phase 2
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
Detailed Description
Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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.
Locations
Centre Hospitalier Universitaire
Angers, France
Status: Recruiting
Contact: Thierry URBAN, Doctor - +33241355844 - thurban@chu-angers.fr
Site 05
Bastia, France
Status: Recruiting
Contact: Jean Cl MOURIES, Doctor - +33495591080 - jcmouries@ch-bastia.fr
Site 22
Beauvais, France
Status: Recruiting
Contact: Eric BOUCHAERT, Doctor
Centre Hospitalier du Morvan
Brest, France
Status: Recruiting
Contact: Gilles ROBINET, Doctor - +33298223428 - gilles.robinet@chu-brest.fr
Centre François Baclesse
Caen, France
Status: Recruiting
Contact: Radj GERVAIS, Doctor - +33231455013 - r.gervais@baclesse.fr
Site 43
Caen, France
Status: Recruiting
Contact: Radj GERVAIS, Professor
Centre Hospitalier René Dubos
Cergy-pontoise, France
Status: Recruiting
Contact: Gislaine FRABOULET, Doctor - +33130754282 - gislaine.fraboulet@ch-pontoise.fr
Site 33
Creteil, France
Status: Recruiting
Contact: Isabelle MONNET, Doctor
Site 07
Draguignan, France
Status: Recruiting
Contact: Hervé LECAER, Doctor - +33 4 94 60 51 12 - herve.lecaer@ch-draguignan.fr
Site 32
Elbeuf, France
Status: Recruiting
Contact: Philippe DAVID
Site 04
GAP, France
Status: Recruiting
Contact: Pascal THOMAS, Doctor - +33 4 92 40 61 26 - pascal.thomas@chicas-gap.fr
Centre Hospitalier Les Oudairies
La Roche Sur Yon, France
Status: Recruiting
Contact: Acya BIZIEUX-TAMINY, Doctor - +33251446164 - acya.bizieux@chd-vendee.fr
Hospital du Cluzeau
Limoges, France
Status: Recruiting
Contact: Alain VERGNENEGRE, Professor - +33 5 55 05 66 29 - avergne@unilim.fr
Centre Hospitalier Régional
Longjumeau, France
Status: Recruiting
Contact: Gérard OLIVIERO, Doctor - +33164543181 - gerard.oliviero@ch-longjumeau.fr
Centre Hospitalier Lyon Sud
Lyon, France
Status: Recruiting
Contact: Laurence GERINIERE, Doctor - +33478861328 - lairence.geriniere@chu-lyon.fr
Site 25
Mantes La Jolie, France
Status: Recruiting
Contact: Jean B AULIAC, Doctor
Site 06
Marseille, France
Status: Recruiting
Contact: Fabrice BARLESI, Doctor - +33 4 91 74 47 36 - fabrice.barlesi@aphm.fr
Site 27
Martigues, France
Status: Recruiting
Contact: Hervé JULLIAN, Doctor
Site 01
Meaux, France
Status: Recruiting
Contact: Francois BLANCHON, Doctor - +33 1 64 35 38 56 - f-blanchon@ch-meaux.fr
Hospital Saint Antoine
Paris, France
Status: Recruiting
Contact: Christos CHOUAID, Professor - +33 1 48 28 25 16 - christos.chouaid@sat.ap-hop-paris.fr
Site 17
Rouen, France
Status: Recruiting
Contact: Dominique PAILLOTIN, DOCTOR
Hôpital Yves Le Foll
Saint Brieuc, France
Status: Recruiting
Contact: Gwenaelle LE GARFF, Doctor - +33296017123 - gwenaelle.legarff@ch-stbrieuc.fr
Site 14
Toulon, France
Status: Recruiting
Contact: Henri BERARD, Doctor
Site 11
Villefranche Sur Saone, France
Status: Recruiting
Contact: Lionel FALCHERO, Doctor - +33 4 74 09 27 23
Start Date
December 2005
Completion Date
May 2010
Sponsors
Groupe Francais De Pneumo-Cancerologie
Source
Groupe Francais De Pneumo-Cancerologie
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page