| CTRI Number |
CTRI/2014/01/004363 [Registered on: 28/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
29/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a phase 3 study of chemotherapy folowed by surgery and postoperative chemotherapy compared to initial surgery followed by chemotherapy in advanced ovarian cancer |
|
Scientific Title of Study
|
A randomized controlled trial of neoadjuvant chemotherapy with interval cytoreduction vs primary cytoreduction in advanced (stage IIIc/IV) epithelial ovarian cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narendra H |
| Designation |
Associate professor |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of surgical oncology
Srivenkateswara institute of medical sciences Tirupati Chittoor district AP
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
917382629699 |
| Fax |
|
| Email |
drnarendrah@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayaprakash |
| Designation |
Senior resident |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of surgical oncology
Srivenkateswara institute of medical sciences Tirupati Chittoor district AP
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
919441450981 |
| Fax |
|
| Email |
jayaprakash27.9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Narendra H |
| Designation |
Associate professor |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of surgical oncology
Srivenkateswara institute of medical sciences Tirupati Chittoor district AP
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
917382629699 |
| Fax |
|
| Email |
drnarendrah@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical sciences |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Alipiri Road Tirupati AP 517507 |
| Type of Sponsor |
Research institution |
|
|
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 Narendra H |
Department of surgical oncology, Sri Venkateswara Institute of Medical Sciences |
Tirupati Chittoor district
Chittoor
ANDHRA PRADESH |
7382629699
drnarendrah@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| svims ethics comittee |
Approved |
| SVIMS ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
epithelial cancer ovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
neoadjuvant chemotherapy with interval cytoreduction |
Paclitaxel 175mg/m2 IV over 3hrs Carboplatin AUC 5-7.5 IV over 1 hour day 1 repeat every 3 weeks total 3 cycles before interval cytoreduction and 3 after |
| Comparator Agent |
Primary cytoreduction followed by chemotherapy |
Paclitaxel 175mg/m2 IV over 3hrs Carboplatin AUC 5-7.5 IV over 1 hour day 1 repeat every 3 weeks for 6 cycles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Previously untreated patients with cytologically/histologically proven ovarian cancer showing peritoneal deposits outside the pelvis of >2cms either clinically/ radiologically
2. Patients with cytological/histologically proven ovarian cancer with regional lymph node metastasis
3. Patients with malignant pleural effusion confirmed to be of ovarian origin,
|
|
| ExclusionCriteria |
| Details |
1. Patients with early stage ovarian cancer and those with peritoneal deposits <2 cms.
2. Patients with distant metastasis except mentioned above.
3. Nonepithelial tumors of ovary such as germ cell tumor, sexcord stromal tumor etc.
4. Patients who have been previously treated or started treatment outside the institute or recurrent lesions will be excluded.
5. Patients with poor performance status or medical contraindications for chemotherapy and/or surgery will be excluded
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare primary debulking surgery followed by chemotherapy and neoadjuvant chemotherapy followed by interval debulking surgery and additional chemotherapy in women with stage IIIc/IV epithelial ovarian carcinoma.
2. To compare operating time, blood loss, organ resections needed, perioperative complications and length of postoperative stay in the two groups. |
February 2015 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the rates of optimal cytoreduction in both the groups
4. To compare loco-regional recurrence rates and disease free survival in the two groups.
|
To compare the rates of optimal cytoreduction in both the groups
4. To compare loco-regional recurrence rates and disease free survival in the two groups.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Ovarian cancer is the second most common gynceological malignancy world wide. In India it is the third most common cancer among women. Most of the women present at an advanced stage leading to higher morbidity and moratality. The current standard treatment to advanced epitehlial ovarian cancer is primary surgery followed by 6 cycles of platinum based adjuvant chemotherapy. There is no level 1 evidence to this approach. An alternate has been recently proposed and tested by some authors. This included initial 3 cycles of platinum based chemotherapy followed by surgery and later additional 3 cycles of chemotherapy. In this study we are comparing these two approaches in a randomized manner. |