Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)

• Conditions: Small Cell Lung Cancer

• Registration Number: NCT00418743
• Lead Sponsor: Groupe Francais De Pneumo-Cancerologie

Brief 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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-08
• Last Update Posted: 2010-03-09
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (24)

Centre Hospitalier Universitaire; 🇫🇷 Angers, France

Site 05; 🇫🇷 Bastia, France

Site 22; 🇫🇷 Beauvais, France

Centre François Baclesse; 🇫🇷 Caen, France

Site 43; 🇫🇷 Caen, France

Centre Hospitalier René Dubos; 🇫🇷 Cergy-pontoise, France

Site 04; 🇫🇷 GAP, France

Centre Hospitalier Les Oudairies; 🇫🇷 La Roche Sur Yon, France

Hospital du Cluzeau; 🇫🇷 Limoges, France

Centre Hospitalier Régional; 🇫🇷 Longjumeau, France

Site 17; 🇫🇷 Rouen, France

Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, France

Site 25; 🇫🇷 Mantes La Jolie, France

Site 06; 🇫🇷 Marseille, France

Site 27; 🇫🇷 Martigues, France

Site 01; 🇫🇷 Meaux, France

Hospital Saint Antoine; 🇫🇷 Paris, France

Site 11; 🇫🇷 Villefranche Sur Saone, France

Site 33; 🇫🇷 Creteil, France

Centre Hospitalier du Morvan; 🇫🇷 Brest, France

Site 07; 🇫🇷 Draguignan, France

Site 32; 🇫🇷 Elbeuf, France

Site 14; 🇫🇷 Toulon, France

Hôpital Yves Le Foll; 🇫🇷 Saint Brieuc, France