| CTRI Number |
CTRI/2026/01/100309 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A research study to compare different chemotherapy treatment options for recurrent ovarian cancer.” |
|
Scientific Title of Study
|
Phase II randomized study evaluating pemetrexed plus carboplatin versus pegylated liposomal doxorubicin plus carboplatin as second-line therapy in platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjana Joel |
| Designation |
PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department Of Medical Oncology
Christian Medical College,Ranipet Campus,Ratnagiri Kilminnal,Tamil Nadu 632517
Vellore
TAMIL NADU
632004
India |
| Phone |
|
| Fax |
|
| Email |
susmit69@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Susmitha Venkitaswamy |
| Designation |
Senior Resident |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department Of Medical Oncology
Christian Medical College,Ranipet Campus,Ratnagiri Kilminnal,Tamil Nadu 632517
Vellore
TAMIL NADU
632517
India |
| Phone |
9080121899 |
| Fax |
|
| Email |
susmit69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Susmitha Venkitaswamy |
| Designation |
Senior Resident |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department Of Medical Oncology
Christian Medical College,Ranipet Campus,Ratnagiri Kilminnal,Tamil Nadu 632517
Vellore
TAMIL NADU
632517
India |
| Phone |
9080121899 |
| Fax |
|
| Email |
susmit69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical college and Hospital,Ranipet Campus,Ratnagiri Kilminnal,TamilNadu 632517 |
| NIL |
|
|
Primary Sponsor
|
| Name |
CHRISTIAN MEDICAL COLLEGE |
| Address |
DEPARTMENT OF MEDICAL ONCOLOGY,
RANIPET CAMPUS,RATNAGIRI KILMINNAL,TAMILNADU,632517 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSusmitha Venkitaswamy |
CHRISTIAN MEDICAL COLLEGE |
Department Of Medical Oncology.
Ranipet Campus,Ratnagiri Kilminnal,Tamilnadu,632517
Vellore
TAMIL NADU |
09080121899
susmit69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (2) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (3) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (4) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (5) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (6) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (7) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (8) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carboplatin with Pemetrexed |
Arm A (Experimental)
Pemetrexed 500 mg/m² IV + Carboplatin AUC 5 IV every 3 weeks × up to 6 cycles
Followed by pemetrexed maintenance every 3 weeks until disease progression or unacceptable toxicity |
| Comparator Agent |
Pegylated liposomal doxorubicin (PLD) |
Pegylated liposomal doxorubicin (PLD) 30 mg/m² IV + Carboplatin AUC 5 IV every 3 weeks × up to 6 cycles
Followed by maintenance therapy as per physician’s choice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Woman more than 18 years old with Performance status 0 to 2
2. Patients previously treated for biopsy-proven epithelial ovarian cancer primary peritoneal cancer or fallopian tube cancer with surgery and platinum-based chemotherapy.
Radiological evidence of disease recurrence occurring at least six months after completion of the last cycle of platinum based chemotherapy
3. Written informed consent obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study
|
|
| ExclusionCriteria |
| Details |
Prior history of radiotherapy which may affect patient tolerability to chemotherapy
2. Patients with congestive heart failure symptomatic NYHA class>=III
3. Pre-treatment documented LV dysfunction and/or ejection fraction <50%
4. Estimated creatinine clearance <45ml/min
Institutional Review Board application form (INTERVENTIONAL), Version 3.4, July 2024 Page 23
5. Patients unable to be regularly followed for any reason (geographic, familial, social,
psychologic).
6. Any mental or physical handicap at risk of interfering with the appropriate treatment.
7. Other malignancy within the last 5 years, except for adequately treated carcinoma in
situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal
cell skin cancer.
8. Mucinous Ovarian Carcinoma
9. Acute intestinal obstruction
Method of randomization:
Randomization will be performed by minimization |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| one year progression-free survival (PFS) |
12 months from Randomisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
overall survival
Quality of Life
Safety & Tolerability |
OS-Analysed at end of study
QOL-Baseline,6 weeks,12 weeks & every 3 months
Safety & tolerability will be asessed throughout the study |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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 2 |
|
Date of First Enrollment (India)
|
19/01/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Advanced-stage epithelial ovarian cancer, including primary peritoneal and fallopian tube cancers, rank among the leading causes of cancer-related mortality in Indian women, reflecting significant morbidity and mortality . In the setting of recurrent ovarian cancer, pemetrexed has emerged as a promising option. Pemetrexed is an antifolate chemotherapeutic agent that disrupts folate-dependent processes critical for DNA synthesis and cell replication This trial aims to evaluate the anti-tumor efficacy, safety, and tolerability of pemetrexed combined with carboplatin with or without bevacizumab compared to pegylated liposomal doxorubicin combined with carboplatin. The study focuses on patients with recurrent epithelial ovarian, peritoneal, or fallopian tube cancers. Primary endpoints include progression-free survival (PFS), while secondary endpoints assess overall survival (OS), quality of life (QoL), and treatment-related toxicities. This trial seeks to provide evidence for optimizing second-line chemotherapy strategies, with a focus on improving survival outcomes and maintaining a better quality of life for women battling recurrent ovarian cancers. |