| CTRI Number |
CTRI/2020/03/023923 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
30/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of acute toxicities and clinical outcome in locally advanced cervical cancer patients treated with two different radiation techniques. |
|
Scientific Title of Study
|
Comparison of acute toxicities and clinical outcome in locally advanced cervical cancer patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshuma Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Patiala |
| Address |
Department of Radiation Oncology, Government Medical College, Rajindra Hospital Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9592096223 |
| Fax |
|
| Email |
dranshubansal3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anshuma Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Patiala |
| Address |
Department of Radiation Oncology, Government Medical College, Rajindra Hospital Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9592096223 |
| Fax |
|
| Email |
dranshubansal3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anshuma Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College PATIALA |
| Address |
Department of Radiation Oncology, Government Medical College, Rajindra Hospital Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9592096223 |
| Fax |
|
| Email |
dranshubansal3@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Govt Medical College Patiala |
| Address |
Department of Radiation Oncology, Government Medical College, Rajindra Hospital Patiala |
| 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 |
| ANSHUMA BANSAL |
Government Medical College, Patiala |
Department of Radiation Oncology, Government Medical College, Rajindra Hospital Patiala
Patiala
PUNJAB |
9592096223
dranshubansal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMC PATIALA |
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 |
RADIATION THERAPY |
ONE GROUP IS RECEIVING RADIOTHERAPY BY 3DCRT TECHNIQUE (THREE DIMENSIONAL CONFORMAL RADIOTHERAPY), AND ANOTHER GROUP IS RECEIVING RADIATION BY VMAT TECHNIQUE (VOLUMATRIC MODULATED ARC RADIOTHERAPY) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Previously untreated, biopsy proven squamous cell carcinoma cervix stage IB2- IIIB.
2.Karnofsky performance scale > 70 (appendix I)
3.Pre treatment parameters :-
a)Age ≤ 70 years
b)HB > 10 gm/dl
c)TLC > 4000/cu mm
d)Platelets > 1 lakh/cu mm
e)Serum urea < 40 mg/dl
f)Serum creatinine < 1.2mg/dl
g)Normal Chest X-ray
4.Patient‟s willingness to give informed consent and agree to follow
|
|
| ExclusionCriteria |
| Details |
1.All post operative cases
2.Medical contraindication for concurrent chemotherapY
3.Patients who have received chemoradiotherapy earlier
5.Patients having any uncontrolled co morbid conditions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Dosimetric comparison of doses to target volumes (PTV, CTV) and OAR (bowel, bone marrow, bladder and rectum) in both the treatment groups.
2. Difference in 2 yr local control rates among the two groups |
Assessment done weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acute gastrointestinal and genitourinary toxicities among the two groups |
Assessment done weekly |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/03/2020 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In Indian setup, there is a major load of cervical cancer patients. Till date, most of our patients were being treated with 3DCRT. Since VMAT planning is time consuming and complex than 3DCRT, our study intends to compare the two conformal techniques in terms of acute toxicities and local response, so that the technique with lesser toxicities and /or better response can be implemented routinely for the treatment of such patients |