| CTRI Number |
CTRI/2010/091/000037 [Registered on: 17/09/2010] |
| Last Modified On: |
22/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of weekly paclitaxel in advanced epithelial ovarian cancer |
|
Scientific Title of Study
|
WEEKLY PACLITAXEL IN COMBINATION WITH CARBOPLATIN EVERY 3 WEEKS FOR ADVANCED EPITHELIAL OVARIAN CANCER: A PHASE 3 RANDOMIZED STUDY
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Lalit Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Room no 234, second floor,
Department of Medical Oncology, AIIMS, Ansari nagar, New Delhi
South
DELHI
110029
India |
| Phone |
01126593405 |
| Fax |
011-26588863 |
| Email |
lalitaiims@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr lalit Kumar |
| Designation |
Professor |
| Affiliation |
Department of Medical Oncology, |
| Address |
Room no 245, second floor, IRCH,
AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
01126593405 |
| Fax |
011-26588863 |
| Email |
lalitaiims@yahoo.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Lalit Kumar |
| Designation |
Professor |
| Affiliation |
Department of Medical Oncology, |
| Address |
Room no 245, second floor, IRCH,
AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
01126593405 |
| Fax |
011-26588863 |
| Email |
lalitaiims@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Department of Biotechnology Ministry of Science and Technology |
| Address |
6th-8th Floor, Block 2
CGO Complex, Lodhi Road
New Delhi - 110 003. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lalit Kumar |
Room No 245, |
Second floor,Dept of Medical Oncology,-110029
New Delhi
DELHI |
01126593405
stemcellaiims@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Epithelial Ovarian Cancer, (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
3 weekly TC |
Paclitaxel 175 mg per m2 IV day 1 every 21 days
Carboplatin AUC6 IV on day 1 every 21 days |
| Intervention |
Dose dense TC |
Paclitaxel 60mg per m2 day 1 8 15 every 21 days
Carboplatin AUC6 day 1 every 21 days |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
a) Cytology proven epithelial ovarian carcinoma, FIGO stage III-IV
b) Age 18-70 years
c) ECOG performance status 0-2
d) Adequate Haemogram
e) Adequate renal and liver function tests
f) Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
a) Patients previously treated with chemotherapy or radiotherapy
b) Pregnancy and lactation
c) Cardiac illness (patients with ejection fraction less than 45%)
d) Pre-existing neuropathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ·To compare the progression free survival in both arms.
·To evaluate the quantitative levels of YKL-40 levels in peripheral blood pre and post treatment. & investigate the prognostic value of this marker.
·To evaluate the quantitative levels of VEGF levels in peripheral blood pre and post treatment and correlate its levels with survival.
|
Basline and post 6 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ·To compare response rates and overall survival between the two groups
·To compare toxicity to chemotherapy in both groups.
·To compare Quality of life in both groups
|
Baseline and post 6 cycles |
|
Target Sample Size
Modification(s)
|
Total Sample Size="270"
Sample Size from India="270"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomised single centre 2 arm trial in advanced ovarian cancer comparing conventional 3 weekly regime of paclitaxel and carboplatin with weekly paclitaxel and carboplpatin for primary treatment after debulking surgery.The primary objective of the study is to compare progression free survival in 2 groups |