| CTRI Number |
CTRI/2021/12/038486 [Registered on: 07/12/2021] Trial Registered Prospectively |
| Last Modified On: |
30/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study outcomes in patients of relapsed and cancer that has spread to other body parts or organs in carcinoma of cervix, post chemotherapy treatment. |
|
Scientific Title of Study
|
“A retrospective analysis of metastatic or recurrent cervical cancer patients treated with palliative systemic therapy and their outcomes: single centre real world data from India.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3797 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushmita Rath |
| Designation |
Associate Professor of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
1109, 11th floor,
Homi Bhabha Block.
E Borges Marg
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
sushmitarath73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushmita Rath |
| Designation |
Associate Professor of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
1109, 11 TH FLOOR
Homi Bhabha Block.
E Borges Marg
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
sushmitarath73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Kembhavi |
| Designation |
Research Manager |
| Affiliation |
Tata Memorial Centre |
| Address |
1109, 11 th floor
Homi Bhabha Block.
E Borges Marg
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
|
| Email |
yogeshkembhavi1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
E Borges marg Parel |
| Type of Sponsor |
Other [Goverment Hospital] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushmita Rath |
Tata Memorial Centre |
Department of Medical Oncology
1109, 11 floor
E Borges Marg
Mumbai
Mumbai
MAHARASHTRA |
02224177201
sushmitarath73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C53||Malignant neoplasm of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Age >18 years with histopathologically confirmed upfront metastatic cervical patients or patients with cervical cancer who have become metastatic/recurred/progressed after prior concurrent chemo radiation or radiation. |
|
| ExclusionCriteria |
| Details |
a. Oligometastatic cervical cancer patients who are planned for treatment with curative intent.
b. Patients treated with palliative radiotherapy only.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the progression-free survival, PFS of metastatic or recurrent cervical cancer patients treated with palliative systemic therapy in our institute from January 2015 to March 2020. The PFS will be from the date of start of palliative treatment till the date of progression |
To estimate the progression-free survival, PFS of metastatic or recurrent cervical cancer patients treated with palliative systemic therapy in our institute from January 2015 to March 2020. The PFS will be from the date of start of palliative treatment till the date of progression |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
I. To estimate the Overall tumour response rates including stable disease, partial response, complete response and progressive disease.
II. Toxicities of therapy: To study the toxicities and tolerance to chemotherapy/bevacizumab/immunotherapy.
III. To estimate the overall survival of patients with metastatic stage IVB/recurrent/persistent cervical cancer patients treated at our institute with palliative systemic therapy from January 2015 to March 2020.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
15/12/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Methodology Study area: Gynaecology oncology disease management group, Tata Memorial Centre, Mumbai. Study population: Metastatic stage IV B cervical cancer patients / recurrent cervical cancer patients who have recurrent or progressive disease planned for palliative intent of treatment. Study period: January 2015 to March 2021. Sample size: All patients in the above time period |