[Randomised phase II study evaluating oral combination chemotherapy (CCNU, cyclophosphamide, etoposide) and intravenous chemotherapy as second-line treatment for relapsed small cell bronchial carcinoma (Trial GFPC0501)].
BACKGROUND
There is no standard second-line treatment for small cell lung cancer (SCLC). The prognosis of these patients is poor and special attention should be paid to both quality of life and economic factors.


METHODS
The aim of this phase II randomised trial (GFPC0501) is to compare, in patients with progressive SCLC after first-line platinum based chemotherapy, oral multi drug chemotherapy (CCNU, cyclophosphamide, etoposide) and classical intravenous chemotherapy with cyclophosphamide, doxorubicin and vincristine (CAV) in terms of tolerability, efficacy (response rate, median one year survival and overall survival), quality of life and consumption of health care resources. Based on a two-stage Bryant and Day approach, this study will require a total of 138 patients with an interim analysis of the first 38.


RESULTS
This trial will provide information on several aspects of second-line chemotherapy for patients with SCLC. Thirty six patients have been enrolled in 16 centres by December 2006 and the results of the interim analysis will be available in June 2007.
Gervais
R
R
Centre Régional de Lutte Contre le Cancer François Baclesse, Caen, France.
Le Guen
Y
Y
Le Caer
H
H
Paillotin
D
D
Chouaid
C
C
D000284:Administration, Oral; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001984:Bronchial Neoplasms / Q000188:drug therapy*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005047:Etoposide / Q000008:administration & dosage* / Q000009:adverse effects; D006295:Health Resources / Q000706:statistics & numerical data; D006801:Humans; D007275:Injections, Intravenous; D008130:Lomustine / Q000008:administration & dosage* / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011788:Quality of Life; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
D000903:Antibiotics, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D000972:Antineoplastic Agents, Phytogenic; D014750:Vincristine; D005047:Etoposide; D008130:Lomustine; D004317:Doxorubicin; D003520:Cyclophosphamide