Personalized radiation therapy for metastatic cervical cancer

A Safety Lead in Single Arm Phase II Study for Image Guided Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) for Treatment of Metastatic Cervical Cancer

This study is testing a new personalized radiation therapy for people with metastatic cervical cancer to see if it can help them live longer while making treatment easier and safer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Texas Southwestern Medical Center (other)
• Drugs / interventions: radiation, immunotherapy
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT05021237 on ClinicalTrials.gov

What this trial studies

This study aims to improve overall survival in patients with metastatic cervical cancer by utilizing personalized ultra-fractionated radiation therapy. The approach involves delivering highly conformal radiation to the primary site while patients continue their standard systemic therapy, minimizing treatment visits and toxicity. By integrating advanced MRI-guided techniques, the study seeks to enhance disease control and potentially improve outcomes for patients receiving immunotherapy. The methodology focuses on balancing treatment efficacy with patient convenience and safety.

Who should consider this trial

Good fit: Ideal candidates include adults with newly diagnosed or recurrent metastatic cervical cancer who are within six months of starting systemic therapy.

Not a fit: Patients with non-metastatic cervical cancer or those who are not candidates for systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with metastatic cervical cancer.

How similar studies have performed: Preliminary data from other cancer types suggest that similar approaches have shown promise, but this specific methodology is novel.

Eligibility criteria

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.

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Kevin Albuquerque, MD — UT Southwestern Medical Center
• Study coordinator: Sarah Neufeld

Conditions: Stage IV Cervical Cancer FIGO 2018, Adenosquamous Carcinoma of Cervix, Cervical Cancer, Metastasis, Cervix