| CTRI Number |
CTRI/2022/03/041034 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two different doses of brachytherapy in endometrial cancer |
|
Scientific Title of Study
|
A prospective randomized control study to compare the effect of two dose schedules used for vault brachytherapy in intermediate risk groups of endometrial cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinivasa G Y |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute Of Medical Education and Research |
| Address |
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9805803262 |
| Fax |
|
| Email |
drsrinivasagowda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srinivasa G Y |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute Of Medical Education and Research |
| Address |
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9805803262 |
| Fax |
|
| Email |
drsrinivasagowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srinivasa G Y |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute Of Medical Education and Research |
| Address |
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9805803262 |
| Fax |
|
| Email |
drsrinivasagowda@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
PGIMER
SEFCTOR 12
CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DRSRINIVASA G Y |
Department of Radiation Oncology |
PGIMER, Sector 12
Chandigarh
CHANDIGARH |
9805803262
drsrinivasagowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C541||Malignant neoplasm of endometrium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
vault brachytherapy |
5Gy HDR per fraction for 5 fractions to be treated daily for 5 consecutive days |
| Comparator Agent |
Vault brachytherapy |
7Gy HDR per fraction for 3 fractions, one fraction every alternate day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Age >18 years
2. ECOG 0-1
3. Histologically confirmed cases of Endometroid endometrial carcinoma
|
|
| ExclusionCriteria |
| Details |
1. Poor performance status
2. Serous or clear cell carcinoma endometrium, sarcoma or carcinosarcoma
3. Stage >1, stage 1a grade 1
4. Uncontrolled Comorbidities
5. No prior history of pelvic radiotherapy
6. Residual macroscopic disease
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the outcome (local control) of vault brachytherapy schedules of 5 Gy x 5 fractions over a week and 7 Gy in 3# in intermediate group endometrial carcinoma.
To compare the toxicities of different brachytherapy schedules in endometrial cancers.
|
Base line, at 3 month first followup, 6 month, 9 month, 12 month, 24 month, 36 month, 48month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare health related quality of life
To evaluate Overall survival and failure free survival
|
Assess quality of life: at 3 month, 6 month, 9 month, 12 month, 2 years, 3 years
Assess the overall survival till death and failure free survival till disease recures |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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 3 |
|
Date of First Enrollment (India)
|
20/03/2022 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Will be made available after sending a request through email
- For how long will this data be available start date provided 08-06-2022 and end date provided 08-02-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
Endometrial cancer is the sixth most common
cancer among the females. Surgery is the mainstay of treatment and adjuvant treatment depends on the
clinicopathological risk factors and the type of surgery undertaken.
Endometrial cancers are stratified as low, low intermediate, high
intermediate and high-risk groups. Recurrence
following initial treatment appears in 10–13% of patients; >70% of
failures appear in the vagina but an extra-pelvic failure can be detected in
>75% of relapse. Prospective studies have demonstrated decreased local
relapse with postoperative radiotherapy, either external beam radiotherapy
(EBRT) or vaginal cuff brachytherapy (VCB). A wide variation of vault
brachytherapy dose schedules has been noted and the studies comparing these
doses are scarce. No optimal dose for VCB has been established; the reported
doses for VCB alone range from 35 to 48 Gy EQD2 and 57 to 69 Gy EQD2 after
EBRT. So this study will aim to compare the effect of various dose schedules
used for vault brachytherapy in intermediate risk groups.
|
|