| CTRI Number |
CTRI/2024/05/067104 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The study compares two types of intervention for cervical cancer participants. first is External beam radiotherapy followed by brachytherapy and external beam radiotherapy followed by VMAT boost |
|
Scientific Title of Study
|
A Comparative Study of The Response And Side Effect In Patient Of
Carcinoma Cervix Treated With Conventional External Beam
Radiotherapy Followed By Hdr Brachytherapy and Vmat Boost
|
| 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 Hemant Jaiswal |
| Designation |
Post Graduate Resident |
| Affiliation |
Pt jnm medical college raipur |
| Address |
Department of radiation oncology Pt jnm medical college raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
7999438178 |
| Fax |
|
| Email |
hemantrjaiswal1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Beck |
| Designation |
Proffesor |
| Affiliation |
Pt jnm medical college raipur |
| Address |
Department of radiation oncology Pt jnm medical college raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9424215915 |
| Fax |
|
| Email |
manjula.raipur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Jaiswal |
| Designation |
Post Graduate Resident |
| Affiliation |
Pt jnm medical college raipur |
| Address |
Department of radiation oncology Pt jnm medical college raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
7999438178 |
| Fax |
|
| Email |
hemantrjaiswal1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiation Oncology room 13 Pt JNM medical college Raipur |
|
|
Primary Sponsor
|
| Name |
Department of Radiation Oncology room no 13 Pt jnm medical college raipur |
| Address |
Pt JNM medical college raipur |
| Type of Sponsor |
Government 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 Hemant Jaiswal |
Linear Accelerator Department of Radiation Oncology Pt JNM medical college Raipur |
Department of Radiation Oncology Pt JNM medical college Raipur
Raipur
CHHATTISGARH |
7999438178
hemantrjaiswal1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Pt. JNM Medical College, Raipur |
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 |
Brachytherapy |
700cGy per fraction for 3 fraction for 56 days |
| Intervention |
External beam radiotherapy |
5000cGy 200cGy per fraction for 25 fraction for 56 days |
| Intervention |
External beam radiotherapy boost |
1600cGy 200cGy per fraction for 8 fraction for 56 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Histologically proven case of carcinoma cervix |
|
| ExclusionCriteria |
| Details |
Patient with metastatic disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the response as per recist criteria |
56 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the radiation induced acute toxicity As per ctcae version five |
56 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
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
|
This interventional study help to assess the response and toxicity of cervical cancer participants treated with External beam radiotherapy with brachytherapy boost versus VMAT boost |