Clinical trial · Interventional
SCLC on the 2nd Line With Relapsed After Response to Chemotherapy GFPC 01-2013
Randomized Study Comparing Two Strategies Carboplatin and Etoposide Topotecan in Patients With SCLC on the Second Row With Relapsed at Least Three Months After Initial Response to Chemotherapy With Platinum-etoposide 6 Cycles
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| CT scans | Device | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A : Carboplatin-Etoposide
- description
- Intravenous administration of Carboplatin Auc 5 at Day 1 and Intravenous administration of 100 mg / m² / of Etoposide J Day 1 to Day 3 The CT scans evaluations will be conducted during chemotherapy every 6 weeks
- interventionNames
- Drug: Carboplatin
- Drug: Etoposide
- Device: CT scans
- type
- ACTIVE_COMPARATOR
- label
- Arm B : Topotecan
- description
- Per os administration of 2.3 mg / m² of Topotecan Day 1 to Day 5 The CT scans evaluations will be conducted during chemotherapy every 6 weeks
- interventionNames
- Drug: Topotecan
- Device: CT scans
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBaize N, Monnet I, Greillier L, Geier M, Lena H, Janicot H, Vergnenegre A, Crequit J, Lamy R, Auliac JB, Letreut J, Le Caer H, Gervais R, Dansin E, Madroszyk A, Renault PA, Le Garff G, Falchero L, Berard H, Schott R, Saulnier P, Chouaid C; Groupe Francais de Pneumo-Cancerologie 01-13 investigators. Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1224-1233. doi: 10.1016/S1470-2045(20)30461-7. PMID 32888454