| CTRI Number |
CTRI/2022/01/039262 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
21/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcomes and quality of life in patients with locally advanced cancers of vulva and vagina. |
|
Scientific Title of Study
|
Clinical outcomes and quality of life in patients with locally advanced vulvovaginal cancers: ambispective registration study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriya Chopra Sastri |
| Designation |
Professor, Radiation Oncology |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
| Address |
PS 246,2nd Floor, Paymaster Shodhika, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930958309 |
| Fax |
|
| Email |
supriyasastri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Chopra Sastri |
| Designation |
Professor, Radiation Oncology |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
| Address |
PS 246, 2nd Floor, Paymaster Shodhika, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930958309 |
| Fax |
|
| Email |
supriyasastri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanshu Tripathi |
| Designation |
Junior Resident, Radiation Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
HBB-1120,
11th floor, Homi Bhabha Block,
Tata Memorial Hospital,
Parel- 400012
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9623429469 |
| Fax |
|
| Email |
priyanshu1511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Centre, Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012 |
| 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 |
| Dr Supriya Sastri |
Tata Memorial Hospital, Advance Centre for Treatment, Research and Education in Cancer |
Room no.L-06, Paymaster Shodhika, ACTREC, Sector 22, Utsav Chowk - CISF Road, Kharghar, Navi Mumbai, Raigad, Maharashtra 410210
Raigarh
MAHARASHTRA |
9930958309
supriyasastri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee I, Tata Memorial Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C519||Malignant neoplasm of vulva, unspecified, (2) ICD-10 Condition: C52||Malignant neoplasm of vagina, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients diagnosed with vulvo-vaginal cancer.
2. Patients treated with Radiation+/- chemotherapy +/- surgery from January 1, 2019- December 31, 2023.
|
|
| ExclusionCriteria |
| Details |
1. Patients with Metastatic disease at the presentation.
2. Incomplete information on the EMR.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To report patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy): RFS, DFS |
3 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To report outcomes as a function of p16, AKT, PDL-1 expression. |
5 Years |
| To report on acute and late effect of treatment outcomes using CTCAE. |
5 Years |
| To report on longitudinal QOL using EORTC QLQ C-30 and VU-34 (English, Hindi, Marathi as applicable) |
4,8,12,16,20,24,30,36,42,48, 54,60 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2022 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The vaginal cancers are responsible for 2% of gynecological cancer while vulvar cancers account for 4 % of gynecological cancers. HPV 16 and 33 are most prevalent in vaginal cancers and account for more than half of cases HPV related vaginal cancer. However, adeqaute information is not there. Similarly, structured QOL data is not available for India. Therefore, in the proposed study we will like to systematically evaluate the patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy). The therapeutic research in vulvo-vaginal cancers has been relatively slow and such structured registration databases can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30 and VU-34) in rare cancers. We hope that we will get help in identifying thrust areas for future research including prospective interventional trials through this study. |