| CTRI Number |
CTRI/2025/12/099927 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study in women with advanced cervical cancer to see whether adding low-dose radiation before standard chemo-radiation improves treatment results and side effects. |
|
Scientific Title of Study
|
A Prospective Study to determine feasibility, Tolerability and efficacy of ultrafractionation along with Induction chemotherapy followed by Concurrent chemoradiotherapy compared to standard Concurrent Chemo-radiotherapy in patients of Locally advanced Squamous cell Carcinoma Cervix |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPGME&R/IEC/2025/0315 |
Protocol Number |
| UTN-U1111-1324-1444 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Younus Mondal |
| Designation |
Junior Registrar Yr 1 |
| Affiliation |
Institute of Post Graduate Medical Education and Research Kolkata |
| Address |
Room no 9
Department of Radiation oncology
Institute of Post Graduate Medical Education and Research
244 A J C Bose Road Kolkata 700020
Department of Radiation oncology
Kolkata
WEST BENGAL
700020
India |
| Phone |
09775328751 |
| Fax |
|
| Email |
younusmondal2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suparna Kanti Pal |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research Kolkata |
| Address |
Room no 9
Department of Radiation oncology
Institute of Post Graduate Medical Education and Research
244 A J C Bose Road Kolkata 700020
Kolkata
WEST BENGAL
Kolkata 700020
India |
| Phone |
7980253154 |
| Fax |
|
| Email |
suparna.k.pal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suparna Kanti Pal |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research Kolkata |
| Address |
Room no 9
Department of Radiation oncology
Institute of Post Graduate Medical Education and Research
244 A J C Bose Road Kolkata 700020
Kolkata
WEST BENGAL
Kolkata 700020
India |
| Phone |
7980253154 |
| Fax |
|
| Email |
suparna.k.pal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiation Oncology, Institute of Post Graduate Medical Education & Research (IPGMER) and SSKM Hospital, Kolkata Institutional resources will be use |
|
|
Primary Sponsor
|
| Name |
Younus Mondal |
| Address |
Room no 9
Department of Radiation oncology
Institute of Post Graduate Medical Education and Research
244 A J C Bose Road Kolkata 700020 |
| Type of Sponsor |
Other [PI in academic Clinical trial (Self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Post Graduate Medical Education and Research Kolkata |
Institute of Post Graduate Medical Education and Research
244 A J C Bose Road Kolkata 700020 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suparna Kanti Pal |
Institute of Post Graduate Medical Education & Research (IPGMER) and SSKM Hospital, Kolkata |
Room no 9
Department of Radiation oncology
Institute of Post Graduate Medical Education and Research
244 A J C Bose Road, Kolkata 700020
Kolkata
WEST BENGAL |
7980253154
suparna.k.pal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER and Research Oversight Committee |
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 |
| Comparator Agent |
Concurrent Chemo radiotherapy with brachytherapy as per standard institutional protocol |
Concurrent Chemo radiotherapy with brachytherapy as per standard institutional protocol |
| Intervention |
Prospective Interventional - single institution feasibility study |
1. Initial Chemotherapy
(a) Injection Paclitaxel 175 mg per square meter in 500 ml normal saline over three hours intravenously on Day 1 every 21 days
(b) Injection Carboplatin Area Under Curve five in five percent dextrose over two hours intravenously every 21 days
(c) Injection Pegfilgrastim 6 mg subcutaneously on Day 2 every 21 days
(d) Number of cycles – Two
(e) Duration of treatment – Six weeks
2. Ultra Fractionated Radiotherapy
(a) Modality: External Beam Radiotherapy (conventional or three-dimensional conformal radiotherapy)
(b) Target volume: Whole pelvis, including pelvic lymph nodes as clinically indicated
(c) Radiation dose: Eighty centigray per fraction, four fractions in total, two fractions per day at least six hours apart for two consecutive days
(d) To be given on the day of chemotherapy and the following day during each initial chemotherapy cycle (two cycles in total)
3. External Beam Radiotherapy (EBRT)
(a) Modality: External Beam Radiotherapy (conventional, three-dimensional conformal radiotherapy, or intensity-modulated radiotherapy)
(b) Target volume: Whole pelvis, including pelvic lymph nodes as clinically indicated
(c) Radiation dose: Forty-five to fifty gray, delivered in daily fractions of 1.8 to 2.0 gray per fraction over approximately five to five and a half weeks
(d) Dose range: Forty-five to fifty point four gray, depending on tumor stage and institutional protocol
(e) To be started fourteen days after completion of initial chemotherapy
4. Concurrent Chemotherapy
(a) Injection Cisplatin 40 mg per square meter in 500 ml normal saline with appropriate pre-medications and pre-hydration every week during the duration of EBRT
(b) To be started on Day 1 of EBRT
(c) Number of cycles – Four to five
5. Brachytherapy
(a) Modality: Interstitial or intracavitary
(b) Dose: As recommended by the International Brachytherapy Society using three-dimensional technique
(c) May be given sequentially or by interdigitating (preferable)
(d) Technique: High Dose Rate
(e) No chemotherapy to be administered on the day of Brachytherapy
6. Duration of Treatment
A total duration of fourteen to sixteen weeks will be considered optimum.
(a) Initial Chemotherapy – Six weeks
(b) Interval period – Two weeks
(c) EBRT and Brachytherapy combined – Six to eight weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Participants must fulfill all of the following criteria to be eligible for the study:
Histopathological confirmation: Carcinoma Cervix (Squamous Cell Carcinoma).
Age: 18.00 years (equivalent to 6,570 days) to 65.00 years (equivalent to 23,725.00 days).
Sex: Female.
Baseline Hematologic Parameters:
a. Hemoglobin greater than or equal to 10.00 grams per deciliter.
b. Total Leukocyte Count greater than or equal to 1,500.00 cells per cubic millimeter.
c. Platelet Count greater than or equal to 100,000.00 per cubic millimeter.
Stage of Disease: FIGO Stage IIB, III, or IVA.
Liver Function Tests:
a. Total Bilirubin less than or equal to 2.00 times the upper normal limit.
b. SGOT and SGPT less than or equal to 3.00 times the upper normal limit.
Renal Function:
a. Estimated Creatinine Clearance greater than or equal to 50.00 milliliters per minute, calculated using the Cockcroft-Gault or MDRD formula. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded from the study if they meet any of the following criteria:
Presence of any other solid tumor within the past five years except skin melanoma treated with local therapy only.
Prior pelvic radiotherapy for any indication.
Presence of vesicovaginal fistula or rectovaginal fistula at presentation, either radiologically or clinically.
History of or current uncontrolled co-morbid conditions which, in the opinion of the investigator, would compromise the safety of the patient.
Known contraindications to radiotherapy.
Any disease where para-aortic nodal irradiation is considered the standard of care.
Known allergies or hypersensitivity reactions to platinum-based drugs, taxanes, arachis oil, or any other drugs to be administered in the study protocol schedule.
Pregnant or lactating women.
Patients unable to provide informed consent or comply with the follow-up protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical and radiological response rates at the first follow-up would be reported as descriptive
statistics. They will be compared with the standard arm |
Clinical and radiological response rates at the first follow-up (6 weeks) would be reported as descriptive
statistics. They will be compared with the standard arm |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. Interventions in the form of surgery or Palliative chemotherapy
2. Any deaths
3. Delay in completion of Scheduled treatment due to any cause. A delay of more than 1 week
would be considered as Prolonged treatment. |
Through the follow up period |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| 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="1"
Months="6"
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
|
Cervical cancer is a significant global health burden and remains one of the leading causes of cancer-related deaths among women, especially in low- and middle-income countries. The standard of care for patients with locally advanced cervical cancer has remained largely unchanged since the National Cancer Institute alert in the 1990s. Although concurrent chemoradiotherapy has significantly improved locoregional control and overall survival compared with radiotherapy alone, treatment failure due to distant metastases still occurs in approximately 30.00 to 35.00 per cent of patients. Recently, the INTERLACE trial, an international phase III randomized study, demonstrated that short-course weekly induction chemotherapy with paclitaxel and carboplatin followed by chemoradiotherapy significantly improves progression-free survival and overall survival in women with locally advanced cervical cancer compared with chemoradiotherapy alone. Preclinical and clinical evidence suggest that in rapidly proliferating tumors such as those of the head and neck region and carcinoma of the cervix, adding small doses of Ultrafractionated radiotherapy to chemotherapy enhances chemosensitivity. This occurs through modulation of the homologous recombination repair and ionizing radiation response pathways, thereby preventing tumor repopulation The present study proposes to explore Short Induction chemotherapy with Ultrafractionated Low dose radiotherapy prior to definitive concurrent chemoradiotherapy.
The Present Trial Protocl proposes to compare the results of addition of two cycles of Induction Chemotherapy with Paclitaxel(175 mg/ m2) and Carboplatin (5AUC) day 1 Q 21 days with Low dose ultrafractionated Radiotherapy ( 80 cGy / fraction , 2 fractions a day, at least 6 hrs apart on the day of induction chemotherapy and the next day) to Standard Concurrent Chemo-Radiotherapy. |