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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Cervical Carcinoma Stage III, Cervical Carcinoma Stage IIB, Cervical Carcinoma Stage II

In brief

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.

Key facts

Study ID

NCT07343531

Run by

Ain Shams University

People needed

30

Starts

2025-07-01

Expected to finish

2027-06-30

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older.
• International Federation of Gynecology and Obstetrics (FIGO) IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy.
• FIGO Stage IB2, IB3, IIA or IIB cervical cancers
• FIGO stage IIIA, IIIB.
• FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria (to avoid extented field technique ): The largest radiologically suspicious positive pelvic node is less than 3 cm. Less than 3 radiologically suspicious positive nodes. No suspicious nodes located in the common iliac chain.
• Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell.
• Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin (Creatinine clearance more than 60 ml/min). Carboplatin AUC 2 is acceptable alternative if cisplatin is not tolerated (creatinine clearance 40:60 ml/min) .
• Brachytherapy candidate.
• Eastern Cooperative Oncology Group (ECOG) performance status up to 2 .

You may not qualify if…

• 1.FIGO stage IA, IIIC2, IVA or IVB. 2.FIGO stage IIIC1 with node is equal or greater than 3 cm, common iliac node or greater than 2 radiologically suspicious nodes.
• Previous pelvic or abdominal radiotherapy. 4.Active inflammatory bowel disease. 5.Active connective tissue disorder (eg. scleroderma, systemic lupus erythematous).
• Patient unable to undergo MR scan 7.Eastern Cooperative Oncology Group (ECOG) performance status equal to 3 or more.
• Creatinine clearance less than 40 ml/min.

Where it is running

• Ainshams University — Cairo, Cairo Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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