NCT07781475Not yet recruiting
Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer
A Randomized Controlled Clinical Trial of Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
This randomized clinical trial will evaluate whether adding spatially fractionated radiation therapy (SFRT) to definitive chemoradiotherapy improves outcomes in patients with locally advanced cervical cancer. Adult patients with FIGO 2018 stage IIB to IVA cervical cancer who are planned to receive definitive chemoradiotherapy will be randomly assigned in a 1:1 ratio to an SFRT group or a control group. Both groups will receive external-beam radiation therapy, concurrent chemotherapy, and brachytherapy. Patients with pelvic wall, rectal, or bladder invasion may also receive immunotherapy as specified in the study protocol. In the experimental group, external-beam radiation therapy will begin with three fractions of SFRT, using a peak dose of 8 Gy per fraction and keeping the valley dose as low as reasonably achievable, generally no more than 3 Gy per fraction. Conventional fractionated external-beam radiation therapy will then begin within 1 to 3 days. Participants in the control group will receive conventional fractionated external-beam radiation therapy without SFRT. The primary objective is to determine whether SFRT improves 3-year progression-free survival. Secondary objectives include objective response rate, treatment safety, overall survival, and the occurrence of an abscopal effect. Exploratory translational studies will evaluate tumor and peripheral blood immune characteristics when biospecimens are available and participants provide consent.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 19 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Aug 2032
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT07781475
What you commit to
- Study type: Interventional
- Planned participants: 126
- From 1 Sept 2026 to the primary completion date, 31 Aug 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe medical comorbidities that preclude the safe administration of radiotherapy.
Other
- Pregnancy or, for women of childbearing potential, inability to use effective contraception.
Who the study is looking for
- Age ≥18 years.
- Histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- FIGO 2018 stage IIB to IVA disease with primary tumor ≥4cm
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Planned to receive definitive chemoradiotherapy.
- Able and willing to provide written informed consent.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Hong Kong-Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.