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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00418743

Enrollment

138

Registered

2007-01-05

Start date

2005-12-31

Completion date

2010-05-31

Last updated

2010-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

cancer, Lung cancer, small-cell lung cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

France

Contacts

Primary ContactChristos CHOUAID, Professor

christos.chouid@sat.ap-hop-paris.fr+33 1 49 28 25 16

Outcome results