| CTRI Number |
CTRI/2024/06/068635 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tumor response and toxicities in cervical cancer patients with a different brachytherapy schedule (where a radioisotope will be kept inside the vaginal cavity to provide internal radiation near the tumor) involving 5 sessions of 6 radiation units each in two applications of a catheter. |
|
Scientific Title of Study
|
Clinical outcomes of cervical cancer with a short intra-cavitary brachytherapy schedule involving 5 sessions of 6Gy each. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhammed Basil Y P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research,JIPMER |
| Address |
Department of Radiation Oncology, Regional Cancer Centre RCC,JIPMER, Dhanvantri Nagar Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7867928123 |
| Fax |
|
| Email |
muhammedbasilyp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parthasarathy V |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER |
| Address |
Department of Radiation Oncology, Regional Cancer Centre RCC,JIPMER, Dhanvantri Nagar Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443601748 |
| Fax |
|
| Email |
dr_patchu2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parthasarathy V |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER |
| Address |
Department of Radiation Oncology, Regional Cancer Centre RCC,JIPMER, Dhanvantri Nagar Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443601748 |
| Fax |
|
| Email |
dr_patchu2003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural Research Fund
Department of Radiation Oncology, Regional Cancer Centre RCC
Jawaharlal Institute of Post Graduate Medical Education and Research,JIPMER
Dhanvantrinagar,Gorimedu,
Pondicherry
Puducherry Pin 605006
India |
|
|
Primary Sponsor
|
| Name |
Dr Muhammed Basil Y P |
| Address |
Department of Radiation Oncology, Regional Cancer Centre RCC
Jawaharlal Institute of Post Graduate Medical Education and Research,JIPMER
Dhanvantrinagar,Gorimedu,
Pondicherry
Puducherry Pin 605006
India |
| 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 Muhammed Basil Y P |
Jawaharlal Institute of Post Graduate Medical Education and Research |
Department of Radiation oncology
Regional Cancer Centre,
Jawaharlal Institute of Post Graduate Medical Education and Research
Dhanvantri Nagar,Gorimedu
Pondicherry
PONDICHERRY |
7867928123
muhammedbasilyp@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 |
Intra cavitary brachytherapy applications of cervical cancer using a different fractionation schedule |
6Grays in 5 sessions using 2 applications. In the first application, 3 sessions of 6Grays each are delivered and in the second application two sessions of 6 Gray each are delivered.
Total duration of this intervention takes 18 hours for first week intervention and 12 hours for second intervention after 1week |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Biopsy-proven newly diagnosed carcinoma cervix
Patients fit for chemotherapy
Age less than 65 years without comorbid conditions
FIGO Stage IB, IIA, IIB, IIIB without lower one-third involvement
ECOG 0-2
No major life-threatening complications
|
|
| ExclusionCriteria |
| Details |
More than 65 years
ECOG 3 or more
Prior pelvic radiotherapy
Uncontrolled Diabetes and hypertension
Patients with a prior history of DVT/Pulmonary embolism
Lower one-third involvement of any stage
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tumor Response in terms of partial or complete response. It will be assessed by clinical or radiological imaging. |
it will be assessed over 2 monthly follow up to 1 year.
The baseline will be the initial tumor size before the application. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acute toxicities like diarrhea, dermatitis, anemia, neutropenia, etc. |
Assessed weekly during radiation therapy |
| Late toxicities which include cystitis & proctitis etc |
6 months up to 1 year |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
20/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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 - NO
|
|
Brief Summary
|
The project title is Clinical outcomes of Cervical Cancer with a short intra-cavitary brachytherapy schedule involving 5 sessions of 6Gy each.
Cervical cancer, a preventable and treatable disease, is still a leading cause of mortality among women in developing countries. As per GLOBOCAN 2020 statistics, 1,23,907 new cases were diagnosed and 77,348 lost their lives in India alone. In a locally advanced cervical cancer combined chemoradiation and brachytherapy is the standard of care treatment. Brachytherapy involves the application of a radioactive source near the tumor. It takes advantage of the inverse-square law, whereby radiation dose is inversely proportional to the square of the distance from the source. In practical terms, this allows for a very high dose to the tumor with relative sparing of the surrounding normal structures. Two applications multi fractionated Brachytherapy augments early completion of treatment which has been explored in cervical cancer, with no increase in acute or late toxicities with improved clinical outcomes in terms of local control, disease free survival, and overall survival by improving compliance and reducing overall treatment time. Individual fraction size be < 7.5Gy and the range of fractions should be 4 to 8; however, many fractionation schedules, varying from institution to institution are in use. We plan to deliver 5 sessions of 6Gy brachytherapy in two settings with a one-week gap and expect an increase in patient compliance with a reduction in overall treatment time.
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