Can pulsed radiation extend life in metastatic cervical cancer?
NCT ID NCT05021237
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing a radiation technique called PULSAR in people with metastatic cervical cancer. PULSAR delivers radiation in short bursts to pelvic tumors, guided by imaging, alongside standard systemic therapy. The trial aims to see whether this approach improves overall survival and measures bladder and bowel side effects. It enrolls 12 adults with newly diagnosed or recurrent metastatic cervical cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR)
- What this could lead to
- If it works, this could offer a way to extend survival for people with metastatic cervical cancer by adding targeted radiation to standard systemic therapy.
- What could go wrong
- This is a small Phase 2 trial with only 12 participants, so results may not hold in larger groups. Radiation to the pelvis can cause bladder and bowel side effects, and the approach may not improve survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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12 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. At least 18 years of age. 2. Ability to understand and the willingness to sign a written informed consent. 3. Newly diagnosed FIGO IVB cervical cancer with radiographic evidence of metastatic disease for whom systemic therapy is standard of care, who are within 6 months of systemic therapy treatment, OR 4. Patients with recurrent/metastatic disease with measurable disease in the pelvis for whom systemic therapy is standard of care and who are within 6 months of initiation of systemic therapy. 5. Patients with brain metastasis are allowed as long as they are clinically stable and/or the mets are treated or are amenable to treatment with radiation and/or surgery. 6. Eastern Cooperative Group (ECOG) performance status of 0-3. 7. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first radiation pulse through 90 days after the last fraction of radiation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Medically acceptable birth control (contraceptives) includes: 1\) approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or 2) barrier methods (such as a condom or diaphragm) used with a spermicide (a substance that kills sperm). A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 8\. Biopsy of primary tumor or recurrent site within 6 months prior to registration Exclusion Criteria 1. Prior radiation treatment to the pelvis, unless it was for palliation with a total of \<=9GY. 2. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study. 3. Patients with active Inflammatory Bowel disease or Collagen vascular disease -SLE, scleroderma or on active immunosuppressant (exclusions per PI discretion). 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. 5. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 6. Presence of brain metastases that are not amenable to treatment with radiation or surgery, or brain metastasis leading to clinical instability.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UT Southwestern Medical Center
Dallas, Texas, 75235, United States
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Other studies related to the condition(s) this trial covers.
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