NCT07343531 A Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer
| NCT ID | NCT07343531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Cervical Carcinoma Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age 18 years or older. 2. International Federation of Gynecology and Obstetrics (FIGO) IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy. 3. FIGO Stage IB2, IB3, IIA or IIB cervical cancers 4. FIGO stage IIIA, IIIB. 5. 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. 6. Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell. 7. 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) . 8. Brachytherapy candidate. 9. Eastern Cooperative Oncology Group (ECOG) performance status up to 2 . Exclusion Criteria: * 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. 3.Previous pelvic or abdominal radiotherapy. 4.Active inflammatory bowel disease. 5.Active connective tissue disorder (eg. scleroderma, systemic lupus erythematous). 6.Patient unable to undergo MR scan 7.Eastern Cooperative Oncology Group (ECOG) performance status equal to 3 or more. 8.Creatinine clearance less than 40 ml/min.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07343531 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Carcinoma Stage III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07343531 currently recruiting?
Yes, NCT07343531 is actively recruiting participants. Contact the research team at manar.adel@med.asu.edu.eg for enrollment information.
Where is the NCT07343531 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07343531 clinical trial?
NCT07343531 is sponsored by Ain Shams University. The trial plans to enroll 30 participants.