| CTRI Number |
CTRI/2026/01/100828 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Survival and Feasibility of Chemotherapy Followed by Chemotherapy plus Radiation Therapy in Patients with Cervical Cancer |
|
Scientific Title of Study
|
A Study on Clinical Outcome with Induction Chemotherapy Followed by Concurrent Chemoradiation in Locally Advanced Cervical Cancer in A Tertiary Care Centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Piyush Ranjan Sahoo |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical sciences and SUM Hospital |
| Address |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia
Khordha
ORISSA
751003
India |
| Phone |
8895478733 |
| Fax |
|
| Email |
ranjan.piyush284@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Surath Panda |
| Designation |
Professor, HOD |
| Affiliation |
Institute of Medical sciences and SUM Hospital |
| Address |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia
Khordha
ORISSA
751003
India |
| Phone |
8895370579 |
| Fax |
|
| Email |
soumyasurathpanda@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Surath Panda |
| Designation |
Professor, HOD |
| Affiliation |
Institute of Medical sciences and SUM Hospital |
| Address |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia
ORISSA
751003
India |
| Phone |
8895370579 |
| Fax |
|
| Email |
soumyasurathpanda@soa.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Piyush Ranjan Sahoo |
| Address |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia. PIN 751029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Piyush Ranjan Sahoo |
Institute of Medical sciences and SUM Hospital |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia
Khordha
ORISSA |
08895478733
ranjan.piyush284@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL Siksha O Anusandhan (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Histopathology-confirmed FIGO 2018 stage IB2-IVA squamous, adenosquamous or adenocarcinoma of the cervix.
2. Medically fit to receive carboplatin and paclitaxel.
3. ECOG performance status 0 – 2
4. Aged 18 and over
5. Adequate renal function (defined as a GFR 60 ml per min or more using the Wright equation), liver function, and hematological profile.
|
|
| ExclusionCriteria |
| Details |
1. Previous pelvic radiotherapy.
2. Recurrent or metastatic disease at diagnosis.
3. Pregnancy or lactation.
4. Other synchronous malignancy.
5. Hydronephrosis, unless relieved by stenting or nephrostomy.
6. Patients who did not consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the objective response rate (ORR) (by RECIST v1.1) |
At baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the progression-free survival (PFS).
2. To evaluate the best response.
3. To assess feasibility: proportion of treatment completion, treatment delays, and discontinuation.
4. To evaluate the toxicity profile (CTCAE v5.0).
|
At baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Cervical cancer remains a major health burden, with
most women in low- and middle-income countries presenting with locally advanced
cervical cancer (LACC). The current standard of care is concurrent
chemoradiation (CCRT) with weekly cisplatin and brachytherapy, although distant
metastases and treatment failure remain significant challenges.
Induction (neoadjuvant) chemotherapy (NACT) has recently
been explored as a strategy to reduce systemic relapse, but prolonged overall
treatment time (OTT) in earlier studies, particularly durations beyond 56 days,
is known to be associated with inferior outcomes.
The phase III INTERLACE trial evaluated a short,
six-week induction regimen with weekly carboplatin–paclitaxel prior to standard
CCRT. The study demonstrated significant improvements in both progression-free
survival (72% vs 64%) and overall survival (80% vs 72%) at five years, while
maintaining acceptable OTT. These results suggest that NACT, if delivered
without delaying definitive therapy, may enhance systemic control and survival
in LACC.
Our study aims to conduct an
analysis of induction chemotherapy followed by CCRT in patients with LACC with
respect to clinical outcomes, real-world feasibility, and the impact on
treatment compliance and toxicity. Such evidence will be critical in
determining whether NACT should be adopted as part of standard management for
LACC. |