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

NCT02738346 | Unknown Phase 3

• 2 other identifiers: CHU-P 2012-08GFPC 01-2013
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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

Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; Topotecan; Etoposide

Outcome Measures

Primary Outcomes (1)

• Benefit in terms of progression-free survival of a therapeutic strategy

  Determine the benefit in terms of progression-free survival of a therapeutic strategy by second-line carboplatin etoposide versus topotecan in patients who relapsed at least three months after the initial chemotherapy with platinum-etoposide.

  18 weeks

Secondary Outcomes (4)

• Objective response rate assessed by RECIST

  18 weeks

• Overall survival

  18 weeks

• Name and number of with treatment-related adverse events as assessed by CTCAE v4.0".

  18 weeks

• The quality of life

  18 weeks

Study Arms (2)

Arm A : Carboplatin-Etoposide

EXPERIMENTAL

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

Drug: Carboplatin; Drug: Etoposide; Device: CT scans

Arm B : Topotecan

ACTIVE COMPARATOR

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

Drug: Topotecan; Device: CT scans

Interventions

Carboplatin DRUG

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

Arm A : Carboplatin-Etoposide

Etoposide DRUG

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

Arm A : Carboplatin-Etoposide

Topotecan DRUG

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

Arm B : Topotecan

CT scans DEVICE

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

Arm A : Carboplatin-Etoposide; Arm B : Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital

Angers, 49933, France

RECRUITING

Related Publications (1)

• Baize 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 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; Etoposide; Topotecan; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Heterocyclic Compounds; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Nathalie BAIZE

  Angers University Hospital Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie BAIZE

CONTACT

NaBaize@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 14, 2016
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 25, 2016

Record last verified: 2016-04

Locations

FR (1)