| CTRI Number |
CTRI/2024/01/061017 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Practicality of selecting tumour volume on Computed Tomography scan taken for Radiation treatment planning, with the help of tumour information obtained from Magnetic Resonance Imaging, so as to improve the cure rates of cervical cancer and to reduce toxicities. |
|
Scientific Title of Study
|
Feasibility of CT based contouring in Image Guided Adaptive Brachytherapy for Carcinoma Cervix using Information from MRI |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/IEC/2023/08/115 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramkumar R |
| Designation |
MD Student |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Radiation Oncology,
Regional Cancer Centre,
JIPMER,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444657978 |
| Fax |
|
| Email |
rrku2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambedkar Yadala |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Radiation Oncology,
Regional Cancer Centre,
JIPMER,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940866067 |
| Fax |
|
| Email |
ambioncologist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambedkar Yadala |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Radiation Oncology,
Regional Cancer Centre,
JIPMER,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940866067 |
| Fax |
|
| Email |
ambioncologist@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Fund Committee, Administrative Block,Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER, Dhanvantary Nagar, Puducherry,605006 |
|
|
Primary Sponsor
|
| Name |
Dr Ramkumar R |
| Address |
Department of Radiation Oncology,
Regional Cancer Centre,
JIPMER,
Puducherry |
| 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 Ramkumar R |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Radiation
Oncology,
Regional Cancer Centre,
JIPMER,
Puducherry
Pondicherry
PONDICHERRY |
9444657978
rrku2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
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 |
Image guided adaptive brachytherapy using information from MRI |
A pre brachytherapy MRI will be taken.The size and volume of the residual tumor from MRI will be identified and used to contour target volumes in brachytherapy simulation CT image in contrast to conventional Point A based treatment. The total intervention time is 4 weeks.1 brachytherapy procedure per week will be done totally accounting for 4 weeks |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Biopsy proven squamous cell carcinoma or adenocarcinoma patients to be treated with radical chemoradiation |
|
| ExclusionCriteria |
| Details |
All postoperative patients
Stage IVB disease patients
Patients who are not fit for chemotherapy
Patients with renal and liver diseases
Immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Local control at 3 months after completion of therapy |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Acute toxicities
|
Assessed weekly during radiation therapy |
| Late toxicity |
4 months |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
04/01/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response (Others) - nil
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response (Others) - nil
- Who will be able to view these files?
Response (Others) - nil
- For what types of analyses will this data be available?
Response (Others) - nil
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2027?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Project title is Feasibility of CT based contouring in Image Guided Adaptive Brachytherapy for Carcinoma Cervix using Information from MRI. Cervical cancer is the second most common cancer among women in India. Combined chemotherapy and brachytherapy is the treatment of choice in locally advanced cervical cancer. In brachytherapy, Point A based dose delivery resulted in good Local Control and Overall Survival but it is not a true anatomical point and, hence, not a true representative of tumor volume. There is a lack of correlation between dose and outcomes. This gave scope for volume based tumor delineation and brachytherapy planning using MRI. Although MRI based tumor delineation and planning are superior, their wide applicability is limited by their availability, logistics, and financial implications. We aim to see the feasibility of using information from clinical examination and MRI information to contour target structures on CT to ensure the delivery of high doses. The primary outcome is to assess the proportion of patients achieving local control at 3 months after completion of therapy. Secondary objectives include dosimetric analysis, acute toxicities, and 2 year overall survival. |