| CTRI Number |
CTRI/2025/01/078998 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Evaluating Treatment Options: Pelvic vs. Extended Field Radiotherapy in Locally Advanced Cervical Cancer" |
|
Scientific Title of Study
|
Pelvic versus extended field radiotherapy in locally advanced pelvic node positive cervical cancer |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swapnil |
| Designation |
Junior resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Radiotherapy,
Post Graduate Institute of Medical Education and Research , Chandigarh
Chandigarh
CHANDIGARH
-160012
India |
| Phone |
7018700273 |
| Fax |
|
| Email |
swapnilbisht08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana Rai |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Radiotherapy,
Post Graduate Institute of Medical Education and Research , Chandigarh
Chandigarh
CHANDIGARH
-160012
India |
| Phone |
9814635706 |
| Fax |
|
| Email |
bhavana1035@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swapnil |
| Designation |
Junior resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Radiotherapy,
Post Graduate Institute of Medical Education and Research , Chandigarh
CHANDIGARH
-160012
India |
| Phone |
7018700273 |
| Fax |
|
| Email |
swapnilbisht08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research , Chandigarh , India
Pin code 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Radiotherapy |
| Address |
Department of Radiotherapy,
Post Graduate Institute of Medical Education and Research , Chandigarh , India
Pin code - 160012 |
| 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 |
| Swapnil |
Post Graduate Institute of Medical Education and Research, Chandigarh, India , Pin code 160012 |
Department of Radiotherapy and Oncology
Chandigarh
CHANDIGARH |
7018700273
swapnilbisht08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER, Chandigarh Institutional Ethics Committee |
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 |
Extended field radiotherapy |
Para aortic nodal volume will be added to the pelvic nodal volume and PTV tumor in Pelvic node positive cervical cancer which will receive 45Gy/25#/5weeks.
Simultaneous integrated boost of 55Gy/25#/5weeks will be delivered to positive pelvic nodes.
Concurrent cisplatin will be given every week with external radiotherapy.
External Radiotherapy will be followed by brachytherapy. |
| Comparator Agent |
Pelvic radiotherapy |
Pelvic nodal volume and PTV tumor in Pelvic node positive cervical cancer will receive 45Gy/25#/5weeks.
Simultaneous integrated boost of 55Gy/25#/5weeks will be given to positive pelvic nodes.
Concurrent cisplatin will be given every week with external radiotherapy.
External Radiotherapy will be followed by brachytherapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. ECOG score of 0-2.
2. Patients with pelvic node metastasis (FIGO 2018 Stage IIIc1).
3.Pelvic lymph node metastasis (pathologic) diagnosed on CT scan/ MRI with highest pelvic node level 1 cm below the aortic bifurcation.
4. Previously untreated, biopsy proven cervical squamous cell carcinoma/ adeno-squamous cell carcinoma.
5. Suitable for concurrent chemoradiation with platinum based chemotherapy
6. Patient’s willingness to give informed consent for the treatment and regular follow up after completion of the treatment throughout the follow up period. |
|
| ExclusionCriteria |
| Details |
1. Patients with para-aortic nodal disease (IIIC2), Stage IVA or Stage IVB disease .
2. Patients with horseshoe kidney.
3. Synchronous malignancy or previous history of malignancy.
4. Presence of uncontrolled or severe comorbidities.
5. Deranged renal function tests.
6. History of pelvic surgery.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the quality of life in both RT arms after chemoradiation followed by brachytherapy. |
Baseline and 3months after completion of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Acute normal tissue response between the two arms. |
1.Acute normal tissue reaction during the treatment and at 3 months after completion of treatment.
|
| Early treatment outcome after completion of RT in both arms. |
At 3 months after 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)
|
20/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
There is a paucity of prospective studies comparing pelvic versus extended field
radiation with concurrent chemotherapy
(CCT).
The current study is based on the
hypothesis that addition of prophylactic Extended Field Radiotherapy is expected to result in better Para- aortic lymph nodal control
and hence, an improved distant control. Further, the
use of image guided external radiotherapy techniques
will allow for dose escalation to the involved pelvic nodes without increasing
morbidity. The goal of this study is to compare EFRT with
standard pelvic radiotherapy in terms of QOL, acute normal tissue response and early treatment outcomes in patients of cervical cancer with pelvic
lymph nodal disease at the time of diagnosis. |