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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738346
Recruitment Status : Unknown
Verified April 2016 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : April 14, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Carboplatin Drug: Etoposide Drug: Topotecan Device: CT scans Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: Arm A : Carboplatin-Etoposide
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
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

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

Active Comparator: Arm B : Topotecan
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
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




Primary Outcome Measures :
  1. Benefit in terms of progression-free survival of a therapeutic strategy [ Time Frame: 18 weeks ]
    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 :
  1. Objective response rate assessed by RECIST [ Time Frame: 18 weeks ]
  2. Overall survival [ Time Frame: 18 weeks ]
  3. Name and number of with treatment-related adverse events as assessed by CTCAE v4.0". [ Time Frame: 18 weeks ]
  4. The quality of life [ Time Frame: 18 weeks ]
    the method of assessment : questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738346


Contacts
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Contact: Nathalie BAIZE NaBaize@chu-angers.fr

Locations
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France
Angers University Hospital Recruiting
Angers, France, 49933
Contact: Nathalie BAIZE       NaBaize@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Nathalie BAIZE Angers University Hospital Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02738346    
Other Study ID Numbers: CHU-P 2012-08
GFPC 01-2013 ( Other Identifier: GFPC )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Keywords provided by University Hospital, Angers:
Small Cell Lung Cancer
Topotecan
Etoposide
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Topotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors