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RECRUITING
NCT07343531
NA

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-07-01

Completion Date

2027-06-30

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Ainshams University

Cairo, Cairo Governorate, Egypt