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

Primary Purpose

Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Carboplatin
Etoposide
Topotecan
CT scans
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, Topotecan, Etoposide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Angers University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A : Carboplatin-Etoposide

Arm B : Topotecan

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Objective response rate assessed by RECIST
Overall survival
Name and number of with treatment-related adverse events as assessed by CTCAE v4.0".
The quality of life
the method of assessment : questionnaire

Full Information

First Posted
April 4, 2016
Last Updated
April 22, 2016
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02738346
Brief Title
SCLC on the 2nd Line With Relapsed After Response to Chemotherapy GFPC 01-2013
Acronym
CBPC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Topotecan is currently the only drug approved in Europe and the United States for the treatment of second line of SCLC when the recovery first line of treatment is considered inappropriate. This raises the problem of knowing when the recovery first line of treatment should be considered appropriate. Secondly, the effectiveness of response to chemotherapy can be predicted based on the response to initial chemotherapy and the time interval after stopping first line treatment. A complete response after initial treatment and a long disease-free interval are predictors of better response to a second-line treatment. There are two groups: the said patients 'sensitive', which correspond to the first-line chemotherapy and who have relapsed at least 90 days after the first-line treatment and a group of so-called patients "Refractory" refers patients who progress in 90 days or patients who have not responded or progressed during first-line treatment. Median survival is very different depending on whether patients with so-called "sensitive" or "refractory". When relapse occurs six months after the end of the first line chemotherapy, the usual practice is to reintroduce the first-line treatment. This is based on old studies where the number of patients included was low. If the interval of time after the first line of treatment is ≥ three months, two second-line treatment strategies are possible resumption of initial chemotherapy or topotecan. The combination of cisplatin with etoposide have shown high response rate, whatever the time of relapse. There are, however, no randomized study in the literature comparing topotecan to the reintroduction of a platinum salt associated etoposide. This study is Randomized, multicenter, controlled, open-label, second line, 2 arms. Arm A : Carboplatin Auc 5 J1 Etoposide 100 mg / m² / J J1 to J3 IV Arm B : topotecan 2.3 mg / m²J1 to J5 po 1 line by Etoposide Cisplatin or carboplatin etoposide Time interval between the first-line chemotherapy and relapse ≥ 90 days (the date is set at J1 of the last cycle) J-28: TDM thoracoabdominal, brain CT or MRI brain, J 7: Biology, quality of life questionnaire (Lung Cancer Symptom Scale). Assessment of tumor response every 6 weeks during chemotherapy post-chemotherapy followed 2nd line: TDM every 8 weeks until progression or death. The duration of the participation of each patient included in the trial will be from inclusion through 12 months. The planned total duration of the trial will be 5 years including 4 years of patient inclusion

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small Cell Lung Cancer, Topotecan, Etoposide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A : Carboplatin-Etoposide
Arm Type
Experimental
Arm 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
Arm Title
Arm B : Topotecan
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Intravenous administration of Carboplatin AUC 5 at Day 1, Every 3 weeks, maximum 6 cycles
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Intravenous administration of 100mg/m²/day of Etoposide, Day 1 to Day 3 Every 3 weeks, maximum 6 cycles
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Per os administration of 2.3 mg / m2 of Topotecan, Day 1 to Day 5 Every 3 weeks, maximum 6 cycles
Intervention Type
Device
Intervention Name(s)
CT scans
Intervention Description
The CT scan evaluations will be conducted during chemotherapy every 6 weeks
Primary Outcome Measure Information:
Title
Benefit in terms of progression-free survival of a therapeutic strategy
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Objective response rate assessed by RECIST
Time Frame
18 weeks
Title
Overall survival
Time Frame
18 weeks
Title
Name and number of with treatment-related adverse events as assessed by CTCAE v4.0".
Time Frame
18 weeks
Title
The quality of life
Description
the method of assessment : questionnaire
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie BAIZE
Email
NaBaize@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie BAIZE
Organizational Affiliation
Angers University Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie BAIZE
Email
NaBaize@chu-angers.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
32888454
Citation
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.
Results Reference
derived

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

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