Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer

Sponsor
The University of Hong Kong-Shenzhen Hospital
Study ID
NCT07781475
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spatially Fractionated Radiation Therapy — RADIATION
    Spatially fractionated external-beam radiation therapy will be delivered in three fractions before conventional fractionated radiation therapy. The prescribed peak dose is 8 Gy per fraction. The valley-to-peak dose ratio will be minimized, with the valley dose generally approximately one-third of the peak dose and usually no more than 3 Gy per fraction. Conventional fractionated external-beam radiation therapy will begin within 1 to 3 days after completion of SFRT.
  • standard of care — RADIATION
    Participants in the control arm will undergo conventional concurrent chemoradiotherapy followed by brachytherapy. Participants in the SFRT arm will first receive SFRT, then receive the same chemoradiotherapy and brachytherapy regimen. For both arms, the decision to add concurrent and consolidation immunotherapy to the backbone treatment will be made according to the latest clinical guidelines and standard practice at the time of treatment.

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2032
Completion
Aug 31, 2035

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SFRT Group
    Participants will receive definitive treatment with external-beam radiation therapy, concurrent chemotherapy, and brachytherapy. External-beam radiation therapy will begin with three fractions of spatially fractionated radiation therapy (SFRT), with a peak dose of 8 Gy per fraction and a valley dose kept as low as reasonably achievable, generally no more than 3 Gy per fraction. Conventional fractionated external-beam radiation therapy will begin 1 to 3 days after SFRT. Patients with pelvic wall, rectal, or bladder invasion will additionally receive immunotherapy as specified by the protocol. Target coverage and normal-tissue dose constraints will follow the same standards as those used in the control group.
  • Active Comparator: Control Group
    Participants will receive standard definitive treatment with conventional fractionated external-beam radiation therapy, concurrent chemotherapy, and brachytherapy. Patients with pelvic wall, rectal, or bladder invasion will additionally receive immunotherapy as specified by the protocol. Target coverage and normal-tissue dose constraints will follow the same standards as those used in the experimental group.

Primary Outcome Measure

3-Year Progression-Free Survival (PFS) Rate [ Time Frame: From randomization to 3 years after randomization ]

Central Contacts

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