NCT07343531

A Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer

A Prospective Phase II Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cancer of the uterine cervix is one of the most common gynecologic cancer diagnosis and cause of death among gynecologic cancers worldwide .The two major histologic types of cervical cancer are squamous cell carcinoma, adenocarcinoma and the preinvasive disease that corresponds with these histologies share many of the same risk factors . Cancer cervix can be treated definitively with concurrent chemoradiation (external beam radiotherapy and chemotherapy) followed by high dose rate brachytherapy. Treatment duration can be shortened by increasing the dose per fraction of treatment, which can improve survival rates, reduce the risk of treatment failure, reduce costs and patient exposure.

Detailed description

The objective of this study is: to assess the clinical response (as a primary endpoint), acute and a two-year late toxicities (as a secondary endpoint) of moderately hypo-Fractionated external-beam radiotherapy with concurrent chemotherapy and high-dose rate brachytherapy in cervical cancer.

Conditions

• Cervical Carcinoma Stage III
• Cervical Carcinoma Stage IIB
• Cervical Carcinoma Stage II

Interventions

Type	Name	Description
RADIATION	moderate hypofractionation external beam radiotherapy	30 patients will receive external beam radiotherapy (EBRT) 40 Gy / 16 fractions with additional 6:10 Gy boost on positive pelvic L.Ns if found either sequential or simultaneous integrated boost (SIB) (according to patient tolerability) with IMRT or VMAT technique followed by High-dose rate (HDR) Brachytherapy 28 Gy /4 fractions 7 Gy per fraction over 2 weeks.Concurrent weekly cisplatin 40 mg/m2 will be received . -Concurrent weekly carboplatin AUC 2 will be received if cisplatin is not tolerated (creatinine clearance 40:60 ml/min) . HDR brachytherapy boost will be given 28 Gy/ 4 fractions 7 Gy per fraction over 2 weeks to be started within a week after the end of external beam radiotherapy sessions.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: Egypt