Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy for Metastatic Cervical Cancer

NCT05021237 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2021-0787
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To improve overall survival in patients with metastatic cervical cancer by loco-regional therapy with personalized ultra-fractionated radiation

Conditions

Stage IV Cervical Cancer FIGO 2018; Adenosquamous Carcinoma of Cervix; Cervical Cancer; Metastasis

Keywords

Cervix

Outcome Measures

Primary Outcomes (1)

• To determine if image guided ultra-fractionated stereotactic adaptive radiotherapy in metastatic/locally recurrent cervical cancer will improve overall survival outcomes

  Overall Survival will be assessed as the percent of patients surviving at each time point. Overall survival is defined as time from diagnosis till death.

  2 years

Secondary Outcomes (2)

• To determine the acute and late genitourinary (GU) and gastrointestinal (GI) toxicities

  90 days

• To evaluate the local-regional progression after treatment

  1 year

Other Outcomes (3)

• To determine the treatment response after each pulse of radiation

  1 year

• To determine QOL in patients treated with radiation

  1 year

• To determine QOL in patients treated with radiation

  1 year

Study Arms (1)

Safety Lead In

EXPERIMENTAL

An interim safety evaluation will be conducted in a minimum of 10 assessable patients who received at least 3 radiation treatments (pulses) with 90 days follow up after radiation OR who experience a dose-limiting toxicity, as defined below. Patients not meeting these requirements will still count towards the overall trial enrollment target, however, the safety lead-in will continue until 10 fully assessable patients are reached (estimate 17 total patients needed for 40% attrition). These patients initially will be enrolled to the base dose-level of 8.5Gy/fraction.

Radiation: Ultra-fractionated radiation therapy

Interventions

Ultra-fractionated radiation therapy RADIATION

Patients enrolled in this study are planned to receive systemic therapy. Imaging based Ultra-fractionated radiation therapy using a PULSAR technique, which is 5 pulses to gross tumor in pelvis.

Safety Lead In

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Ability to understand and the willingness to sign a written informed consent.
• 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
• 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.
• 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.
• Eastern Cooperative Group (ECOG) performance status of 0-3.
• 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:
• \) 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).
• \. Biopsy of primary tumor or recurrent site within 6 months prior to registration

You may not qualify if:

• Prior radiation treatment to the pelvis, unless it was for palliation with a total of \<=9GY.
• Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
• 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.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• Presence of brain metastases that are not amenable to treatment with radiation or surgery, or brain metastasis leading to clinical instability.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Elekta Limited: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Albuquerque, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective Therapeutic Study

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (1)