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

NCT02738346 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2016-04-25

No results posted yet for this study

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

Conditions

Interventions

DRUG

Carboplatin

Intravenous administration of Carboplatin AUC 5 at Day 1, Every 3 weeks, maximum 6 cycles

DRUG

Etoposide

Intravenous administration of 100mg/m²/day of Etoposide, Day 1 to Day 3 Every 3 weeks, maximum 6 cycles

DRUG

Topotecan

Per os administration of 2.3 mg / m2 of Topotecan, Day 1 to Day 5 Every 3 weeks, maximum 6 cycles

DEVICE

CT scans

The CT scan evaluations will be conducted during chemotherapy every 6 weeks

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Nathalie BAIZE · Angers University Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02738346 on ClinicalTrials.gov