| CTRI Number |
CTRI/2008/091/000028 [Registered on: 11/04/2008] |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A double blind clinical trial comparing the study drug and placebo as second line therapy for treatment of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)?. |
Scientific Title of Study
Modification(s)
|
A multinational, randomized, double-blind study comparing aflibercept versus
placebo in patients treated with second-line docetaxel after failure of one platinum
based therapy for locally advanced or metastatic non-small-cell lung cancer
(NSCLC) |
| Trial Acronym |
VITAL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EFC10261 |
Protocol Number |
| NCT00532155 |
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 (I) Ltd |
| Address |
54/A.Sir Mathuradas Vasanji Road
Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707806 |
| Fax |
|
| Email |
Gayatri.jaiswal@sanofi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Gayatri Jaiswal |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo (I) Ltd |
| Address |
54/A.Sir Mathuradas Vasanji Road
Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707806 |
| Fax |
|
| Email |
Gayatri.jaiswal@sanofi.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 - 93 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Indonesia
Democratic People's Republic of Korea |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr.Murali Rao |
Dept. of Medicine |
New Block,King George Hospital-530002
|
91-891-2712755
91-891-2714644
|
| Dr.Shafiq Hussain |
Kidwai Memorial Institute Of Oncology |
Dr.M.H. Marigowda Road,,-560029
Bangalore
KARNATAKA |
91-8026578557
91-80-26565671
|
| DrGBBhattacharyya |
Orchid Nursing Home |
P-17, CIT Road,
Scheme VI M, Phoolbagan,
Kolkata-700054, West Bengal. India
Kolkata
WEST BENGAL |
9831011517
docgs@hotmail.com |
| Ms.Poonam More |
Ruby Hall Clinic |
Grand Medical Foundation,,Sasoon hospital-
Pune
MAHARASHTRA |
91-9823133390
91-20-66455604
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee,Poona Medical Research Foundation-Pune/Minish Jain |
Submittted/Under Review |
| Institutional Ethics Committee-King George Hospital-Vishakhapatnam/Ravimohan Pedapenki |
Submittted/Under Review |
| Institutional Review Board, Orchid Nursing Home/Kolkata/G S Bhattacharya |
Submittted/Under Review |
| Medical EC, Kidwai Memorial Institute of Oncology/Bangalore/ K Govindbabu |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, Non Small Cell Lung Cancer, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Aflibercept+docetaxel |
Aflibercept :6 mg/kg over 1 hour IV on Day 1 every 3 weeks
Docetaxol 75 mg/m² IV over 1 hour, on Day 1.
|
| Comparator Agent |
Placebo+docetaxel |
Aflibercept
6 mg/kg will be administered IV over 1 hour once on Day 1, every 3 weeks
Placebo: 6 mg/kg will be administered IV over 1 hour once on Day 1 every 3 weeks,
Placebo: 6 mg/kg will be administered IV over 1 hour once on Day 1 every 3 weeks,
Immediately after aflibercept/placebo administration, all the patients will receive docetaxel: 75
mg/m2
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
? Histological/cytological proven locally advanced or metastatic non-small cell lung cancer
? Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease
? Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
? Adequate renal, liver and bone marrow functions
|
|
| ExclusionCriteria |
| Details |
? Squamous histology/cytology
? Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
? Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 25% of bone marrow
? Prior docetaxel treatment
? Uncontrolled hypertension
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To demonstrate overall survival (OS) improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC). |
Clinical examination will be performed every 3 weeks before each treatment cycle during the treatment period and then overall survival will be evaluated by collecting status information at 2 month intervals until death or the study cut-off date, whichever comes first |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Progression Free Survival (PFS) |
PFS is defined as time interval between the date of randomization and the time of occurrence of the first documented among the following events:
• Radiological tumor progression on CT scan and /or MRI
• Death due to any cause |
|
Target Sample Size
Modification(s)
|
Total Sample Size="900"
Sample Size from India="23"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
29/03/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
19/09/2007 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Clinical Study Report |
|
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 24 countries all over the world The Indian target - 40 patients Indian status - No patients randomized till date Planned date of first enrolment - 10th Apr 2008 India randomised 23 patients in the study. Randomisation ended on 5th February 2010. |