Personalized Ultra-Fractionated Stereotactic Adaptive Radiotherapy for Metastatic Cervical Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05021237

This study aims to improve survival rates in patients with metastatic cervical cancer by using a personalized approach to radiation therapy that targets the cancer in the pelvic area.

Patient Parameters

Program Overview

The goal of this study is to enhance the survival of patients with metastatic cervical cancer by using a specialized form of radiation therapy that is tailored to each patient. This approach focuses on treating the cancer in the pelvic region while continuing with standard treatments.

Description

Metastatic cervical cancer can be challenging to treat, and despite advances in treatment, outcomes are often not as good as hoped. This study is exploring a new way to improve results by using a personalized radiation therapy approach. The idea is to target the main cancer site in the pelvis with a type of radiation called PULSAR, which is delivered in five sessions. This method is designed to work alongside standard treatments without causing delays or interruptions.

The study aims to reduce the number of treatment sessions to make it more convenient for patients and to minimize side effects. By using advanced imaging techniques, the radiation can be precisely targeted, which helps to lower the risk of side effects. Additionally, this approach may enhance the effectiveness of other treatments, such as immunotherapy, for those who are receiving it.

Overall, the study seeks to improve disease control, prevent uncomfortable symptoms, and potentially increase survival rates for patients with metastatic cervical cancer.

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).

    1. 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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