1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [janejessica25@gmail.com].
   


6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2035?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Scientific Title
Clinical outcomes of cervical cancer with single application in situ HDR brachytherapy involving 8 Gy x 3 fractions following a course of pelvic EBRT a prospective clinical study

Public Title
Study on outcomes of cervical cancer using a shorter single application brachytherapy schedule after external radiotherapy

Brief Summary
This is a prospective single centre interventional study conducted at JIPMER Puducherry. The study evaluates the clinical outcomes of patients with biopsy proven cervical cancer Stage IB to IIIB ECOG 0 to 2 age less than 70 years treated with standard pelvic external beam radiotherapy EBRT with or without concurrent chemotherapy followed by a single application of high dose rate HDR intracavitary brachytherapy delivering 8 Gy x 3 fractions. The primary aim is to assess locoregional control at 6 months after completion of treatment. Secondary aims include assessment of acute and late toxicities using CTCAE version 5 criteria and overall treatment compliance. The trial will recruit 48 patients over 2 years. This regimen is expected to provide comparable tumor control with acceptable toxicity while reducing overall treatment time and improving compliance in the Indian setting.

Study Design
Type Interventional prospective single arm clinical study
Allocation Non randomized convenience sampling
Duration 2 years

Primary Outcome
Locoregional control at 6 months post radiotherapy complete or no complete response as per RECIST version 1.1 criteria.

Secondary Outcomes
Acute and early toxicities less than 6 months graded by CTCAE version 5.0
Late toxicities more than 6 months
Overall treatment compliance and treatment related complications

Inclusion Criteria
Biopsy proven newly diagnosed cervical carcinoma
Stage IB IIA IIB IIIB without lower one third vaginal involvement
Age less than 70 years
ECOG performance status 0 to 2
No major life threatening comorbidities
Willingness to comply with protocol and provide informed consent

Exclusion Criteria
Age more than 70 years
ECOG 3 or more
Prior pelvic radiotherapy
Uncontrolled diabetes or hypertension
Prior history of DVT or pulmonary embolism
Pregnancy or lactation
Lower one third vaginal involvement

Sample Size
48 patients accounting for 10 percent attrition

Intervention
External beam radiotherapy with or without concurrent chemotherapy as per protocol
HDR intracavitary brachytherapy single application delivering 8 Gy x 3 fractions

Study Setting
Department of Radiation Oncology Regional Cancer Centre JIPMER Puducherry India

Estimated Duration
Recruitment 2 years
Follow up 5 years every 2 months up to 6 months every 4 months up to 3 years every 6 months up to 5 years