Hypofractionated Chemoradiotherapy for Cervical Cancer
Official title: HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical Cancer (HYPOCx Trial): A Phase III Randomized Controlled Trial
Run by Mahidol University · NCT07709650 · Data updated 2026-11-12
This trial tests whether giving higher-dose, shorter-course chemoradiotherapy to the pelvis (with or without extended-field treatment) works as well as or better than standard longer-course treatment for people with cervical cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bangkok Noi, Bangkok) |
| Status | Recruiting |
| Started | August 3, 2026 |
| Main results expected | June 2031 |
| Study ends | June 2033 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07709650 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with cervical cancer (squamous, adenocarcinoma, or adenosquamous) at locally advanced stages suitable for definitive radiochemotherapy, with adequate kidney function and no prior pelvic/adominal radiotherapy.
✕Probably not a fit
Patients with contraindications to radiation or chemotherapy, extensive metastatic disease, or significantly reduced organ function may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 trial compares hypofractionated whole pelvic or extended-field chemoradiotherapy delivered with concurrent chemotherapy to conventional fractionated chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. Building on prior Phase II safety and efficacy signals, the study aims to determine nodal control and overall survival with shorter treatment courses while monitoring safety. Eligible participants have biopsy-confirmed cervical cancer suitable for definitive radiochemotherapy and meet imaging and organ function criteria. The trial is led by Mahidol University with Siriraj Hospital, enrolling at Siriraj Hospital in Bangkok, Thailand.
Why it matters
Potential benefit: If successful, participants may experience similar or improved cancer control with a shorter, potentially more convenient treatment schedule and maintained safety.
How similar studies have gone: Previous Phase II results suggested safety and potential efficacy for hypofractionated approaches in cervical cancer, but high-level evidence in the extended-field setting remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including imaged-guided BT 2. Positive biopsy showing squamous-cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma of the uterine cervix 3. Locally advanced staging according to FIGO 2018 and TNM guidelines (Stage IA1-IVA) 4. MRI of the pelvis at diagnosis is performed 5. MRI, CT, or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed 6. MRI with the applicator in place at the time of (first) BT will be performed 7. GFR ≥ 50 mL/min 8. Patient informed consent Exclusion Criteria: 1. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin 2. Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix 3. Metastatic disease beyond intervertebral disc L2/3 level 4. Previous pelvic or abdominal radiotherapy 5. Previous total or subtotal hysterectomy 6. Combination of preoperative radiotherapy with surgery 7. Patients receiving BT only 8. Patients receiving EBRT only 9. Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/m2). 10. Contra-indications to MRI 11. Contra-indications to BT
Where it's running
-
Siriraj Hospital
Bangkok Noi, Bangkok, Thailand Recruiting
Study contacts
- Study coordinator: Tissana Prasartseree, MD
- Email: tissana.p@gmail.com
- Phone: 66625246101
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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.