Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy for Metastatic Cervical Cancer

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Aug 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new type of radiation therapy for women with advanced cervical cancer that has spread to other parts of the body (called metastatic cervical cancer). The goal is to see if a personalized and highly targeted radiation treatment can help these patients live longer. This trial is specifically for women aged 18 and older who have recently been diagnosed with this type of cancer or have had it return after treatment. Participants should also be within six months of starting standard treatments for their cancer and must be in good enough health to follow the study requirements.

If you or a loved one qualifies and decides to participate, you can expect to receive a unique radiation treatment tailored to your specific condition. It’s important to note that women who can become pregnant will need to use effective birth control during the trial and for three months after the treatment ends. Overall, this study aims to explore a promising approach to improve outcomes for women facing this challenging diagnosis.

Gender

FEMALE

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.