NCT07709650 Hypofractionated Chemoradiotherapy for Cervical Cancer
| NCT ID | NCT07709650 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mahidol University |
| Condition | Cervival Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-08-03 |
| Primary Completion | 2031-06 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2026-08-03 with a primary completion date of 2031-06.
⚠ 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
The goal of this clinical trial is to evaluate whether hypofractionated whole pelvic or extended-field concurrent chemoradiotherapy can improve treatment access and efficiency while potentially providing superior oncologic efficacy and safety compared to conventional chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. Building on encouraging safety and efficacy outcomes from our Phase II HYPOCx-iRex trial (TCTR20210812003), this study will provide data for a critical evidence gap regarding the safety, feasibility, and oncologic efficacy of hypofractionated radiotherapy, including extended-field para-aortic treatment, delivered with concurrent chemotherapy. The main questions it aims to answer are: * Does hypofractionated chemoradiotherapy achieve superior nodal control compared to conventional chemoradiotherapy? * Does hypofractionated chemoradiotherapy achieve superior overall survival compared to conventional chemoradiotherapy? Researchers will compare patients receiving hypofractionated external beam radiotherapy to those receiving conventional fractionation to evaluate if the shortened hypofractionated schedule provides comparable disease control, acceptable toxicity, improved quality of life, and cost-effectiveness. Participants will: * Be randomized to receive either hypofractionated external beam radiotherapy or conventional fractionation radiotherapy, both delivered using modern IMRT/VMAT techniques targeting either the whole pelvis or extended fields (including para-aortic lymph nodes). * Receive concurrent platinum-based chemotherapy during external beam radiation. * Complete image-guided adaptive brachytherapy following external beam radiotherapy. * Attend scheduled follow-up visits to evaluate tumor response, disease control, treatment-related toxicities, quality of life, and survival outcomes.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07709650 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervival Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07709650 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT07709650 currently recruiting?
Yes, NCT07709650 is actively recruiting participants. Contact the research team at tissana.p@gmail.com for enrollment information.
Where is the NCT07709650 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand.
Who is sponsoring the NCT07709650 clinical trial?
NCT07709650 is sponsored by Mahidol University. The trial plans to enroll 250 participants.
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