Cervical CancerSFRT-LACCNCT07781475
Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer
A study testing Spatially Fractionated Radiation Therapy in people with Cervical Cancer, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Spatially Fractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Aug 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe medical comorbidities that preclude the safe administration of radiotherapy.
- Pregnancy or, for women of childbearing potential, inability to use effective contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The University of Hong Kong - Shenzhen Hospital,
Shenzhen, Guangdong, 518053
Zhiyuan Xu, MD,PhD, +86 075586913333 ext. 2107, Xuzy@hku-szh.org
Zhiyuan Xu, MD,PhD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cervical Cancer
- Being tested
- Spatially Fractionated Radiation Therapy, standard of care
- Keywords
- Spatially Fractionated Radiation Therapy, Lattice Radiation Therapy, Locally Advanced Cervical Cancer, Definitive Chemoradiotherapy, Brachytherapy, Radiation Therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatially Fractionated Radiation TherapyRadiation
Also called SFRT
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 careRadiation
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 group | Role | What they receive |
|---|---|---|
| SFRT Group | Experimental | 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. Receives: Radiation: Spatially Fractionated Radiation Therapy; Radiation: standard of care |
| Control Group | Active comparator | 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. Receives: Radiation: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to 3 years after randomization
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From randomization to death from any cause, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2032 (estimated)
- Study completion31 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either spatially fractionated radiation therapy followed by conventional definitive chemoradiotherapy or conventional definitive chemoradiotherapy alone.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhi-yuan, The University of Hong Kong-Shenzhen Hospital
- Investigators
- Zhiyuan Xu, MD,PhD, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781475
- Sponsor's protocol ID
- hkuszh2025094
- Acronym
- SFRT-LACC
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amendola 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.
PubMed 36077802
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT07781475
- Acronym / sponsor ID
- SFRT-LACC / hkuszh2025094
- Conditions
- Cervical Cancer
- Keywords
- Spatially Fractionated Radiation Therapy, Lattice Radiation Therapy, Locally Advanced Cervical Cancer, Definitive Chemoradiotherapy, Brachytherapy, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2032 (estimated)
- Study completion
- 31 Aug 2035 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either spatially fractionated radiation therapy followed by conventional definitive chemoradiotherapy or conventional definitive chemoradiotherapy alone.
| Arm | Type | Receives |
|---|---|---|
| SFRT Group | Experimental | Radiation: Spatially Fractionated Radiation Therapy, Radiation: standard of careParticipants 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. |
| Control Group | Active comparator | Radiation: standard of careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Severe medical comorbidities that preclude the safe administration of radiotherapy.
- Pregnancy or, for women of childbearing potential, inability to use effective contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatially Fractionated Radiation TherapyAlso: SFRTSpatially 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. | Radiation | SFRT Group |
| standard of careParticipants 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. | Radiation | Control Group, SFRT Group |
Primary outcome
3-Year Progression-Free Survival (PFS) Rate
Time frame: 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.
4 secondary outcomes
Objective Response Rate (ORR) at 3 Months After Radiotherapy
Time frame: 3 months after completion of radiotherapy
Incidence of Acute Adverse Events
Time frame: From the first day of treatment through 90 days after completion of radiotherapy
Incidence of Late Radiation Toxicity
Time frame: From more than 90 days after completion of radiotherapy through 5 years after randomization
Overall Survival (OS)
Time frame: From randomization to death from any cause, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 36077802Amendola 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiyuan Xu, MD,PhD principal investigator
The University of Hong Kong-Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatially Fractionated Radiation Therapy in people with Cervical Cancer, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyuan Xu, MD,PhD (+86 075586913333 ext. 2107, Xuzy@hku-szh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Progression-Free Survival (PFS) Rate (time frame: From randomization to 3 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.