| CTRI Number |
CTRI/2024/02/062998 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
life expectancy in cervical cancer patients after treatment. |
|
Scientific Title of Study
|
Long term clinical outcomes and toxicity in cervical cancer patients treated with surgery and chemoRadiation-An institutional observational study. |
| 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 J Prasanthi |
| Designation |
Associate professor |
| Affiliation |
Government medical college,hospital,ananthapuramu. |
| Address |
op room no.1,cancer unit,Radiation oncology department,Government cancer hospital,college,sharadha nagar,ananthapuramu,andhrapradesh
Anantapur
ANDHRA PRADESH
510051
India |
| Phone |
9885028646 |
| Fax |
|
| Email |
prasanthijuturu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinakar kootala |
| Designation |
assistant professor |
| Affiliation |
Government medical college,hospital,ananthapuramu. |
| Address |
op room no.2,cancer unit,Radiation oncology department,Government cancer hospital,college,sharadha nagar,ananthapuramu,andhrapradesh
Anantapur
ANDHRA PRADESH
510051
India |
| Phone |
8897444722 |
| Fax |
|
| Email |
dinakarkmc1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinakar kootala |
| Designation |
assistant professor |
| Affiliation |
Government medical college,hospital,ananthapuramu. |
| Address |
op room no.2,cancer unit,Radiation oncology department,Government cancer hospital,college,sharadha nagar,ananthapuramu,andhrapradesh
Anantapur
ANDHRA PRADESH
510051
India |
| Phone |
8897444722 |
| Fax |
|
| Email |
dinakarkmc1@gmail.com |
|
|
Source of Monetary or Material Support
|
| cancer unit,Government general hospital,sharada nagar,anantapuramu,andhrapradesh |
|
|
Primary Sponsor
|
| Name |
J prasanthi |
| Address |
cancer unit,Government general hospital,college,anantapuramu |
| 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 dinakar |
government general hospital |
oncology OP department,cancer unit,sharada nagar,ananthapuramu
Anantapur
ANDHRA PRADESH |
8897444722
dinakarkmc1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical college,anantapuramu.INSTITUTIONAL ETHICS COMMITTEE regd no:191 of 2014 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C538||Malignant neoplasm of overlappingsites of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Histopathologically confirmed cervical cancer patients,squamous cell carcinoma or adenocarcinoma, underwent surgery and chemo radiation with curative intent treatment,and having tumors with FIGO stage I or stage II. |
|
| ExclusionCriteria |
| Details |
Cervical cancer patients treated with palliative intent.
Patients previously treated with either surgery or chemo radiation.
Patients treated with radical chemoradiation
Patients who are not on regular follow up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival |
Overall survival is the period from the date of surgery to date of death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disease free survival |
Disease free survival is the period from the date of surgery to disease recurrence or last follow up. |
| Toxicity |
In this trial we are evaluating late toxicity, which occurs after three months of completion of treatment. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/02/2024 |
| 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="3"
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
|
Worldwide Cervical cancer is the fourth most common cancer among women both in incidence with an estimated 604,000 new cases and deaths with 342,000 cases. In India it accounts for 75,209 new cases with cumulative risk of 1 in 75 females next to breast cancer in which 1 in 29 females will develop cancer. At our hospital around 25% of total patients that we treat will be having cervical cancer. Treatment options for early stage cervical cancer are either surgery or radiation. Overall survival or disease free survival are equal for either treatment. Some selected patients after surgery based on certain pathological risk factors have to receive adjuvant radiation with or without concurrent chemotherapy that results in improved disease outcomes.patients who receive post operative radiation will be having increase in complications. Most of the trials conducted on combined modality treatment are older studies moreover treatment methods also changed over period of time with the advent of newer techniques. The aim of the present study is to report 5 year disease related outcomes and complications in cervical cancer patients treated surgery and radiation at Government College, hospital. |