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

Groupe Francais De Pneumo-Cancerologie

Status: Unknown

Conditions: Small Cell Lung Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00418743

GFPC 05-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.