An interventional study of Spatially Fractionated Radiation Therapy and standard of care in Cervical Cancer, sponsored by The University of Hong Kong-Shenzhen Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by The University of Hong Kong-Shenzhen Hospital · Not applicable, Interventional, and Treatment
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.
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 126 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →The University of Hong Kong-Shenzhen Hospital is the lead sponsor of 16 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Radiation: Spatially Fractionated Radiation Therapy · Radiation: standard of care
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.
Radiation: standard of care
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.
Also known as: SFRT
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.
3-Year Progression-Free Survival (PFS) Rate
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.
Time frame: From randomization to 3 years after randomization
Objective Response Rate (ORR) at 3 Months After Radiotherapy
Objective response rate is defined as the percentage of evaluable participants who achieve a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), based on post-treatment imaging assessment.
Time frame: 3 months after completion of radiotherapy
Incidence of Acute Adverse Events
The number and percentage of participants experiencing adverse events from the first day of study treatment through 90 days after completion of radiotherapy. Acute adverse events will be graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time frame: From the first day of treatment through 90 days after completion of radiotherapy
Incidence of Late Radiation Toxicity
The number and percentage of participants experiencing late radiation-related toxicities by grade. Late toxicity is defined as toxicity occurring more than 90 days after completion of radiotherapy and will be assessed using the Radiation Therapy Oncology Group late radiation morbidity scoring criteria.
Time frame: From more than 90 days after completion of radiotherapy through 5 years after randomization
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the last follow-up will be censored at the date of their last known follow-up.
Time frame: From randomization to death from any cause, assessed up to 5 years
Plan to share: Undecided
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong-Shenzhen Hospital