Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Spatially Fractionated Radiation Therapy: 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: 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 summary

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.

Eligibility

Primary outcome measure(s)

• 3-Year Progression-Free Survival (PFS) Rate — From randomization to 3 years after randomization
  The percentage of participants who are alive without disease progression at 3 years after randomization. Progression-free survival is defined as the time from randomization to the first documented recurrence or progression at any site or death from any cause, whichever occurs first.

Trial sites (1)

More The University of Hong Kong-Shenzhen Hospital trials in China

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