RecruitingNot ApplicableNCT07343531

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


Sponsor

Ain Shams University

Enrollment

30 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether delivering radiation in fewer but slightly larger daily doses (moderately hypofractionated radiotherapy) combined with chemotherapy and internal radiation (brachytherapy) is as effective and safe as the standard radiation schedule for women with locally advanced cervical cancer. **You may be eligible if...** - You are 18 or older - You have confirmed cervical cancer (squamous cell, adenocarcinoma, or adenosquamous), at FIGO stages IB1–IIB, IIIA, IIIB, or selected IIIC1 cases - You are a candidate for definitive chemoradiotherapy (combined chemotherapy and radiation as your primary treatment) - You can receive weekly cisplatin or carboplatin chemotherapy - You are suitable for internal radiation (brachytherapy) - You are in adequate physical condition (ECOG 0–2) **You may NOT be eligible if...** - Your cancer is stage IA, IIIC2, IVA, or IVB - You have had previous pelvic or abdominal radiation - You have active inflammatory bowel disease or a connective tissue disorder (e.g., lupus, scleroderma) - You cannot have an MRI scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONmoderate 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

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NCT07343531