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NCT Number: NCT07781475

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong - Shenzhen Hospital,

Shenzhen, Guangdong, 518053, China

Location contact

Zhiyuan Xu, MD,PhD

CONTACT

[email protected]

+86 075586913333 ext. 2107

Zhiyuan Xu, MD,PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spatially fractionated radiation therapy

Radiation

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.

Other names: SFRT

STANDARD OF CARE

Radiation

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Objective Response Rate (ORR) at 3 Months After Radiotherapy

    Time frame: 3 months after completion of 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.

  2. Incidence of Acute Adverse Events

    Time frame: From the first day of treatment through 90 days after completion of radiotherapy

    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).

  3. Incidence of Late Radiation Toxicity

    Time frame: From more than 90 days after completion of radiotherapy through 5 years after randomization

    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.

  4. Overall Survival (OS)

    Time frame: From randomization to death from any cause, assessed up to 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiyuan Xu, MD,PhD

CONTACT

[email protected]

+86 075586913333 ext. 2107

Sponsors and collaborators

Lead sponsor

The University of Hong Kong-Shenzhen Hospital

Other

Registry information

Official study title

A Randomized Controlled Clinical Trial of Spatially Fractionated Radiation Therapy for Locally Advanced Cervical Cancer

Acronym: SFRT-LACC

Important dates

Study start
2026
Primary completion
2032
Study completion
2035
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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