Shorter-course external-beam radiotherapy with weekly chemotherapy and high-dose-rate brachytherapy for 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
This tests whether a moderately shortened schedule of external radiotherapy given with weekly chemotherapy plus high-dose-rate brachytherapy helps people with stage IB–IIIC1 cervical cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07343531 on ClinicalTrials.gov |
What this trial studies
Patients receive moderately hypofractionated external-beam radiotherapy given concurrently with weekly cisplatin (carboplatin AUC2 allowed if cisplatin is not tolerated), followed by high-dose-rate intracavitary brachytherapy. The primary outcome is clinical response, with secondary outcomes including acute toxicity and two-year late toxicity. Eligible participants include adults with histologically confirmed squamous, adenocarcinoma, or adenosquamous cervical cancer in specified FIGO stages, and selected IIIC1 nodes meeting size/number limits. The regimen is delivered at a single center (Ain Shams University) with protocol-specified imaging and toxicity monitoring.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed cervical cancer in FIGO IB1 (if not surgical candidates), IB2, IB3, IIA, IIB, IIIA, IIIB, or selected IIIC1 disease who are candidates for definitive chemoradiotherapy and brachytherapy with adequate renal function are ideal candidates.
Not a fit: Patients with extensive nodal disease (e.g., pelvic nodes ≥3 cm, more than three suspicious nodes, or common iliac/common para-aortic involvement), those not eligible for brachytherapy, or with poor renal function may not benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the approach could shorten overall treatment time, reduce costs and clinic visits, and maintain or improve cancer control compared with conventional fractionation.
How similar studies have performed: Moderately hypofractionated external-beam regimens have been tested in limited series and pilot trials with encouraging convenience and acceptable short-term toxicity, but they are less well established than standard fractionation for cervical cancer.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo, Cairo Governorate
- Ainshams University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Manar Adel, master degree
- Email: manar.adel@med.asu.edu.eg
- Phone: +201066760941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.