Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spatially Fractionated Radiation Therapy | Radiation | — | UNRESOLVED |
| standard of care | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SFRT Group
- description
- 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.
- interventionNames
- Radiation: Spatially Fractionated Radiation Therapy
- Radiation: standard of care
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Severe medical comorbidities that preclude the safe administration of radiotherapy. * Pregnancy or, for women of childbearing potential, inability to use effective contraception.
References
Publications (1)
- BACKGROUNDAmendola BE, Mahadevan A, Blanco Suarez JM, Griffin RJ, Wu X, Perez NC, Hippe DS, Simone CB 2nd, Mohiuddin M, Mohiuddin M, Snider JW, Zhang H, Le QT, Mayr NA. An International Consensus on the Design of Prospective Clinical-Translational Trials in Spatially Fractionated Radiation Therapy for Advanced Gynecologic Cancer. Cancers (Basel). 2022 Aug 31;14(17):4267. doi: 10.3390/cancers14174267. PMID 36077802