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Spatially Fractionated Radiation Added to Standard Treatment for Locally Advanced Cervical Cancer

Tests adding spatially fractionated radiation to standard treatment in adults with advanced cervical cancer.

Plain-language title generated from the registry record
Registry title: Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer

Key facts

Where
Shenzhen, ChinaSee the site

Where in China

  • The University of Hong Kong-Shenzhen HospitalShenzhen, ChinaNo longer taking part

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Trial details

Who runs it
The University of Hong Kong-Shenzhen Hospital
Trial code
NCT07781475
Record updated
24 August 2026
Original description
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.Read full original descriptionShow less

A Randomized Controlled Clinical Trial of Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer

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.

Inclusion: 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.

Exclusion: Severe medical comorbidities that preclude the safe administration of radiotherapy; Pregnancy or, for women of childbearing potential, inability to use effective contraception.

ClinicalTrials.gov NCT07781475