Cervical CancersPhase 2NCT07022470
Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
A Phase 2 study testing 3-Fraction HDR Brachytherapy and 4-Fraction HDR Brachytherapy in people with Cervical Cancers, run by Stanford University at 1 site in United States.
Trial summary
This is a prospective non-randomized clinical trial to evaluate the feasibility of 3 fraction versus a standard 4 fraction high dose rate brachytherapy regimen in patients with locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- 3-Fraction HDR Brachytherapy and 4-Fraction HDR Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to Jun 2028
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented malignancy of the cervix and planned to receive brachytherapy as part of definitive treatment.
- ECOG performance status of 0-2
- Age ≥ 18 years old.
- Ability to understand and the willingness to provide written informed consent.
Who cannot join
- Contraindication to receiving radiotherapy as determined by treating radiation oncologist.
- Contraindication to receiving MRI.
- Prior radiation to the pelvis > 3 months ago
- Age < 18 years old.
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Alyssa Yauger, 650-498-5271, ayauger@stanford.edu
Jillian Skerchak, (650) 721-4072, jskerch1@stanford.edu
About this study
Official title: Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
This is a prospective non-randomized clinical trial to evaluate the feasibility of 3 fraction versus a standard 4 fraction high dose rate brachytherapy regimen in patients with locally advanced cervical cancer.
- Conditions
- Cervical Cancers
- Being tested
- 3-Fraction HDR Brachytherapy, 4-Fraction HDR Brachytherapy
- Keywords
- high dose rate brachytherapy
- 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.
3-Fraction HDR BrachytherapyRadiation
8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.
4-Fraction HDR BrachytherapyRadiation
7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| 3-Fraction Brachytherapy Arm | Experimental | Patients who meet dosimetric criteria at the first brachytherapy session (HR CTV D90 > 85 Gy and acceptable OAR constraints) will receive an investigational 3-fraction HDR brachytherapy regimen (24 Gy total). Receives: Radiation: 3-Fraction HDR Brachytherapy |
| Investigational Treatment | Active comparator | Patients who do not meet dosimetric criteria for the investigational regimen will receive the institutional standard-of-care regimen of 4 fractions (28 Gy total). Receives: Radiation: 4-Fraction HDR Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen
Proportion of patients that underwent a 3 fraction brachytherapy regimen.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start3 Jun 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Kidd, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022470
- Sponsor's protocol ID
- IRB-79234
- Other IDs
- NCI-2025-06274
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
- ClinicalTrials.gov ID
- NCT07022470
- Acronym / sponsor ID
- IRB-79234
- Conditions
- Cervical Cancers
- Keywords
- high dose rate brachytherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Jun 2025 (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 is a prospective non-randomized clinical trial to evaluate the feasibility of 3 fraction versus a standard 4 fraction high dose rate brachytherapy regimen in patients with locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-Fraction Brachytherapy Arm | Experimental | Radiation: 3-Fraction HDR BrachytherapyPatients who meet dosimetric criteria at the first brachytherapy session (HR CTV D90 > 85 Gy and acceptable OAR constraints) will receive an investigational 3-fraction HDR brachytherapy regimen (24 Gy total). |
| Investigational Treatment | Active comparator | Radiation: 4-Fraction HDR BrachytherapyPatients who do not meet dosimetric criteria for the investigational regimen will receive the institutional standard-of-care regimen of 4 fractions (28 Gy total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically documented malignancy of the cervix and planned to receive brachytherapy as part of definitive treatment.
- ECOG performance status of 0-2
- Age ≥ 18 years old.
- Ability to understand and the willingness to provide written informed consent.
Key exclusion criteria (5 listed)
- Contraindication to receiving radiotherapy as determined by treating radiation oncologist.
- Contraindication to receiving MRI.
- Prior radiation to the pelvis > 3 months ago
- Age < 18 years old.
- Pregnant or breast-feeding
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 |
|---|---|---|
| 3-Fraction HDR Brachytherapy8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning. | Radiation | 3-Fraction Brachytherapy Arm |
| 4-Fraction HDR Brachytherapy7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen. | Radiation | Investigational Treatment |
Primary outcome
Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen
Time frame: Up to 8 months
Proportion of patients that underwent a 3 fraction brachytherapy regimen.
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 12 Jun 2026.
Related trials for Cervical Cancers
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Elizabeth Kidd, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3-Fraction HDR Brachytherapy and 4-Fraction HDR Brachytherapy in people with Cervical Cancers, run by Stanford University at 1 site in United States.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Jun 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alyssa Yauger ((650) 498-5271, ayauger@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen (time frame: Up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.