Treatment of cervical cancer with hypofractionated chemoradiotherapy
Official title: Comparison of Clinical Response and Toxicity of Hypo-fractionated Chemoradiation With Standard Treatment in Patients With Uterine Cervix Cancer
Run by Tehran University of Medical Sciences · NCT04831437 · Data updated 2026-11-12
This study is testing a new way of giving radiation and chemotherapy to see if it works just as well as the standard treatment for people with cervical cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Tehran University of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tehran) |
| Status | Recruiting |
| Started | April 1, 2021 |
| Main results expected | March 2023 |
| Study ends | March 2028 |
| Registry record updated | October 12, 2021 |
| Trial ID | NCT04831437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix at FIGO stages IB to IIIC.
✕Probably not a fit
Patients with creatinine clearance less than 30ml/min, previous pelvic radiotherapy, or those with FIGO stage IA or IV are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness and safety of hypofractionated chemoradiotherapy compared to conventional treatment for patients with cervical cancer stages IB to IIIC. A total of 60 eligible patients will be randomly assigned to receive either hypofractionated external beam radiotherapy (EBRT) or standard EBRT, both combined with weekly chemotherapy. The study will assess clinical responses and toxicities at various intervals post-treatment using MRI and standardized toxicity criteria. The goal is to determine if the hypofractionated approach is non-inferior to the standard treatment in terms of efficacy and side effects.
Why it matters
Potential benefit: If successful, this approach could lead to shorter treatment durations and reduced healthcare costs for patients with cervical cancer.
How similar studies have gone: While the concept of hypofractionation is being explored in various cancers, this specific approach in cervical cancer is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathology of squamous cell carcinoma (SCC), adenocarcinoma, adenosquamous carcinoma of uterine cervix- International Federation of Gynecology and Obstetrics (FIGO) stage IB, IIA, IIB, IIIA, IIIB (due to hydronephrosis without creatinine clearance compromise), IIIC1 (if less than 3 lymph nodes with size less than 3cm, and without involvement of common iliac chain)- Patient eligible for definitive chemoradiotherapy followed by brachytherapy Exclusion Criteria: * Creatinine clearance less than 30ml/min, any histology other than the above, requirement of paraaortic lymph node irradiation, inflammatory bowel disease, connective tissue disorders, previous pelvic radiotherapy, FIGO stage IA or IV, Eastern Cooperative Oncology Group (ECOG) performance status greater than 2, History of previous hysterectomy
Where it's running
-
Imam Khomeini Hospital Complex
Tehran, Iran Recruiting
Study contacts
- Principal investigator: Afsaneh Maddah-Safaei, M.D. — Tehran University of Medical Sciences
- Study coordinator: Kasra Kolahdouzan, M.D.
- Email: k-kolahdouzan@razi.tums.ac.ir
- Phone: +989144083785
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.