| CTRI Number |
CTRI/2025/12/098858 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate benefit of new chemotherapy in weak patients with advanced ovarian cancer |
|
Scientific Title of Study
|
Efficacy and safety of Carboplatin with Pemetrexed or Paclitaxel for frail women with advanced ovarian, peritoneal, or fallopian tube cancer: an open-label, randomized, phase 2 trial |
| Trial Acronym |
GRACEFUL - Gentler Regimen for Advanced ovarian Cancer Evaluation in Frail Unfit Ladies |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Singh |
| Designation |
|
| Affiliation |
Christian Medical College, Vellore |
| Address |
Head of the department and Professor
Department of Medical Oncology
Christian Medical College
Ranipet 632517
Vellore
TAMIL NADU
632517
India |
| Phone |
9445659460 |
| Fax |
|
| Email |
todrashish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Singh |
| Designation |
Professor and Head of the Department |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Medical Oncology
Christian Medical College
Ranipet - 632517
Vellore
TAMIL NADU
632517
India |
| Phone |
9445659460 |
| Fax |
|
| Email |
todrashish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Singh |
| Designation |
Professor and Head of the Department |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Medical Oncology
Christian Medical College
Ranipet - 632517
Vellore
TAMIL NADU
632517
India |
| Phone |
9445659460 |
| Fax |
|
| Email |
todrashish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medical Oncology,
Christian Medical Oncology,
Ranipet 632571 |
|
|
Primary Sponsor
|
| Name |
CMC |
| Address |
Department of Medical Oncology,
Christian Medical College,
Ranipet - 632517 |
| Type of Sponsor |
Private medical college |
|
|
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 Jennifer Koil Sudahar |
Christian Medical College, Ranipet |
Room no.17,
Department of Medical Oncology,
Christian Medical College,
Ranipet 632517
Vellore
TAMIL NADU |
7094277315
jennyforj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Paclitaxel and Carboplatin |
Paclitaxel 175 mg/m2, I.V. and carboplatin AUC 5, I.V. every 3 weeks total of 6 cycles OR Carboplatin (AUC 2 mg/mL per min) and Paclitaxel (60 mg/m 2 ) intravenously every week of 21 day cycle total of 6 cycles |
| Intervention |
Pemetrexed and Carbopaltin |
Pemetrexed 500mg/m2, I.V. and Carboplatin AUC 5, I.V. every 3 weeks total of 6 cycles followed by maintenance Pemetrexed 500mg/m2 till maximum of 4 cycles
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Woman more than or equal to 18 years old
2. Histologically or cytologically proven FIGO stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125 divided by CEA more than 25 and pelvic mass in radiological imaging
3. Frail patients according to Frailty Deficit Index (FI) score - frailty is defined as an FI more than or equal to 0.15
4. Written informed consent obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study
5. Required initial laboratory parameters:
a. Absolute Neutrophil Count more than or equal to 1,000/mm3
b. Hemoglobin greater than 10.0 g/dL
c. Platelets more than or equal to 100,000/mm3
d. Total Bilirubin less than 1.5x ULN (Upper Limit of Normal)
e. Serum ALT less than 2.5 x ULN
f. Estimated creatinine clearance more than 60 ml/min(MDRD equation or Cockcroft Gault formula)
g. PT/INR less than 1.5 x ULN |
|
| ExclusionCriteria |
| Details |
1. FIGO Stage I or II
2. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
3.Major surgical procedure within 28 days prior to randomization or
anticipation of need for major surgery during the course of study, other than that required for the ovarian cancer treatment itself
3. 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
4. Prior history of chemotherapy for the present malignancy
5. Prior history of radiotherapy which may affect patient tolerability to chemotherapy
6. Documented baseline neuropathy CTCAE v5.0 grade greater than or equal to 2
7. Patients with congestive heart failure symptomatic NYHA class greater than or equal to III
8. Pre-treatment documented LV dysfunction and/or ejection fraction less than 50%
9. Estimated creatinine clearance less than 60ml/min
10. Patients unable to be regularly followed for any reason (geographic, familial, social, psychologic)
11. Any mental or physical handicap at risk of interfering with the appropriate treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progression free survival |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect on surgical outcomes : Assess the feasibility of achieving optimal cytoreductive surgery after three cycles of chemotherapy |
after 3 chemotherapy cycles |
| Chemotherapy Completion Rate: Assess the proportion of patients who successfully complete all 6 planned chemotherapy cycles |
after 6 chemotherapy cycles |
| Survival (OS): Evaluate the overall survival rates of patients within each treatment arm |
at 3 years, 5 years |
| Safety and Tolerability: Monitor and evaluate the incidence and severity of treatment-related adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
after each chemotherapy cycles |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
15/12/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Epithelial ovarian cancer is the third most common cancer in Indian women, with high mortality. Frail patients experience excessive toxicity from standard carboplatin-paclitaxel, while single-agent carboplatin yields inferior outcomes. Pemetrexed, with its favorable safety profile and efficacy in relapsed disease, may offer a better-tolerated alternative. This trial evaluates whether carboplatin-pemetrexed improves tolerability without compromising efficacy compared to standard therapy in frail patients (Frailty Index more than or equal to 0.15).This study tests whether a gentler chemotherapy combo (carboplatin-pemetrexed) works as well as standard treatment but with fewer side effects in frail ovarian cancer patients. If successful, it could offer a safer option for frail women.
|