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

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