| CTRI Number |
CTRI/2008/091/000036 [Registered on: 02/04/2008] |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer (CILAB) |
Scientific Title of Study
Modification(s)
|
Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer |
| Trial Acronym |
CILAB |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EFC6668 |
Protocol Number |
| NCT00625664 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Gayatri Jaiswal |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
54/A.Sir Mathuradas Vasanji Road
Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707806 |
| Fax |
02230707843 |
| Email |
Gayatri.jaiswal@sanofi-aventis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Gayatri Jaiswal |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
54/A.Sir Mathuradas Vasanji Road
Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707806 |
| Fax |
02230707843 |
| Email |
Gayatri.jaiswal@sanofi-aventis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Sanofi Synthelabo (India) Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Sanofi Synthelabo India Limited |
| Address |
54/A, Sir Mathuradas Vasanji Road,
Andheri (East)
Mumbai – 400 093
India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
France
Poland
Romania
Russian Federation
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 001 |
Andhra Medical College |
,-
|
|
| Dr Raju Titus Chako |
Christian Medical College |
Dept. of Medical Oncology, Vellore, TamilNadu
Vellore
TAMIL NADU |
4162283040
rchacko@cmcvellore.ac.in |
| 003 |
Kidwai Memorial Institute of Oncology |
,-
|
|
| 005 |
Nizam’s Institute of Medical Sciences, Panjagutta |
,-
|
|
| 004 |
Ram Manohar Lohia Hospital and PGIMER |
,-
|
|
| 002 |
Safdarjung Hospital |
,-
|
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| EC of Chittaranjan National Cancer Institute, Kolkata, Dr Jaydip Biswas |
Submittted/Under Review |
| EC of DR. RAM MANOHAR LOHIA HOSPITAL & PGIMER, Rajeev Sood |
Submittted/Under Review |
| EC of VMMC & SAFDARJANG HOSPITAL NEW DELHI |
Submittted/Under Review |
| EC_KingGeorgeHospital_Vishakhapattanam_RavimohanPedapanki |
Submittted/Under Review |
| INSTITUTIONAL REVIEW BOARD(ETHICS COMMITTEE) CHRISTIAN MEDICAL COLLEGE, Dr Raju Chako |
Submittted/Under Review |
| Medical EC of Kidwai Memorial Hospital, Dr K Govind Babu |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bladder Cancer , (1) ICD-10 Condition: N328||Other specified disorders of bladder, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Gemcitabine+Cisplatin |
Gemcitabine 1000mg/m² on Day 1, 8, and 15 administered as a 30minute infusion |
| Intervention |
Larotaxel+Cisplatin |
Larotaxel 50 mg/m² IV over 1h on day 1 Cisplatin75 mg/m² |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer
2.ECOG Performance Status ≤ 2
3.No prior palliative chemotherapy
|
|
| ExclusionCriteria |
| Details |
1. (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse
2.Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization
3.Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m²
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To compare overall survival (OS) of patients administered larotaxel in combination with cisplatin vs. gemcitabine in combination with cisplatin for the treatment of locally advanced /metastatic urothelial tract or bladder cancer
|
The primary efficacy endpoint is the Overall Survival (OS) that is defined as the time from the date of randomization to death with all cause.
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To compare Progression Free Survival (PFS), Objective
Response Rate (ORR), time to definitive deterioration of PS, Duration of Response (DR), and time to definitive 5% weight loss of larotaxel in combination with cisplatin vs. gemcitabine combined with cisplatin.
To assess the safety and tolerability of larotaxel in
combination with cisplatin and gemcitabine with cisplatin
|
Secondary efficacy endpoints are PFS, ORR, time to infinitive deterioration of PS, DR, and time to definitive 5% weight loss.
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="900"
Sample Size from India="13"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
09/01/2008 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/02/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
CSR |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Trial will be conducted in 21 countries all over the world. From India 13 patients were enrolled in the study.
|