SCLC on the 2nd Line With Relapsed After Response to Chemotherapy GFPC 01-2013

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine prospectively in all patients with SCLC in second line therapy that progression-free survival with the expected reintroduction of platinum / etoposide is greater progression-free survival in the standard arm (topotecan ) in patients who have relapsed at least three months after initial chemotherapy with platinum-etoposide

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Topotecan

Criteria

Inclusion Criteria:

• Lung Cancer Small cell histologically confirmed.

• SCLC stage IV according to the TNM classification in 2009

• Relapse localized SCLC treated with chemoradiotherapy if they are outside the radiation field.

• Patients who have had an objective response to first-line chemotherapy with cisplatin and etoposide or carboplatin and etoposide and have a time interval > or = 90 days between relapse and first-line chemotherapy (the date is set J1 of the last cycle)

• At least one-dimensionally measurable disease (RECIST)

• Age > or = 18 years

• Weight loss <10% during the last 3 months

• Performance status (PS) < or = 2

• Creatinine clearance> 45 ml / min.

• Neutrophils >1,5X10 9 / L and platelets > 100X109 / L.

• Bilirubin < 1,5 X normal.

• Transaminases, alkaline phosphatase < 2,5 X normal except in cases of hepatic metastases (5 X normal).

• Informed Consent signed

• Patients with asymptomatic brain metastases may be included

• Prophylactic brain irradiation based on the habits of each center defined in advance

Exclusion Criteria:

• Lung cancer non-small cell or mixed form (small cell / non-small cell) or absence of histological evidence

• SCLC stage I or stage II or stage III.

• Patients who have not had an objective response to first-line chemotherapy with cisplatin and etoposide or carboplatin and etoposide or that have a time interval < 90 days between relapse and first-line chemotherapy (the date is defined in J1 of the last cycle)

• Serum Na < 125 mmol / L

• Hypercalcemia despite corrective treatment

• Brain metastases or symptomatic meningeal

• A history of malignancy within the last 5 years with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix.

• Other concomitant serious medical conditions: congestive heart failure, unstable angina, significant arrhythmia or previous myocardial in the previous six months trial

• Severe or uncontrolled systemic diseases, the investigator found incompatible with the proposed protocol

• Neurological and psychiatric disorders prohibiting comprehension test

• Severe infectious disease during or fever > 38 ° C

• Peripheral neuropathy > or = grade 2

• Any geographical or psychological condition does not allow a proper understanding and compliance with the protocol.

• Private Patient freedom following a judicial or administrative decision

• Pregnant woman, parturient or nursing; Women of childbearing potential and men with a woman of childbearing age must have adequate contraception for the duration of the study and up to 6 months after treatment ends.

• Patient in an exclusion period for another Biomedical study