A Randomized Controlled Clinical Trial of Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer
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 Criteria:
Exclusion Criteria:
Xuzy@hku-szh.org+86 075586913333 ext. 2107
This is an investigator-initiated, randomized, parallel-group clinical trial evaluating spatially fractionated radiation therapy in patients with locally advanced cervical cancer. A total of 126 participants with histologically confirmed FIGO 2018 stage IIB to IVA cervical cancer will be enrolled and randomly assigned in a 1:1 ratio to the experimental SFRT group or the control group.
Participants in both groups will receive definitive treatment consisting of 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-volume coverage and normal-tissue dose constraints will follow the same standards in both treatment groups.
In the experimental group, external-beam radiation therapy will begin with three fractions of spatially fractionated radiation therapy. The peak dose will be 8 Gy per fraction. The valley-to-peak dose ratio will be kept as low as reasonably achievable, 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 1 to 3 days after SFRT. The higher radiation dose within selected intratumoral regions constitutes the main difference between the experimental and control groups.
The primary endpoint is 3-year progression-free survival. Secondary endpoints include objective response rate according to RECIST version 1.1, acute and late treatment-related toxicity, overall survival, and abscopal effect rate. Optional translational analyses will investigate changes in tumor PD-L1 expression, tumor and peripheral blood immune-cell subsets, and transcriptomic characteristics.
Xuzy@hku-szh.org+86 075586913333 ext. 2107