Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers

NCT06538337 | Recruiting DMC FDA Device

• 1 other identifier: 23-001976
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

After surgery to remove the main endometrial and/or cervical tumor, most women receive radiation therapy. This study uses hypo-fractionated radiation therapy, which is a type of radiation therapy in which the total prescribed dose of radiation is delivered in fewer but larger doses than conventional or standard radiotherapy. This research study aims to determine if hypo-fractionated radiation therapy given after surgery can improve treatment tolerability (i.e., fewer treatments) with comparable side effects. Participants will be in the study for about 5 years: Radiation therapy:

• 5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).
• Each treatment session will occur on a weekday (typically consecutive weekdays) and will last approximately an hour. Treatment Follow-Up:
• Check-up Appointment and answer questions at 3 months post RT
• Check-up Appointments with physical exam every 6 months (+/- 4 weeks) for up to 5 years.

Conditions

Endometrial Cancer; Cervical Cancer

Keywords

endometrial; cervical; SBRT

Outcome Measures

Primary Outcomes (1)

• Evaluate acute radiation toxicity

  Evaluate acute radiation toxicity according to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0). Acute toxicity is defined as treatment-related adverse events occurring within 12 weeks of completion of radiotherapy.

  treatment to 12 weeks after completion of radiotherapy

Secondary Outcomes (7)

• Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)

  treatment to 24 weeks after completion of radiotherapy

• Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-EN24)

  treatment to 24 weeks after completion of radiotherapy

• Evaluate late toxicity

  12 weeks after completion of radiotherapy until 5 years after completion of radiotherapy

• Evaluate local control

  treatment to 5 years after completion of radiotherapy

• Evaluate regional control

  treatment to 5 years after completion of radiotherapy

Study Arms (1)

Hypofractionated External beam Radiotherapy

EXPERIMENTAL

5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).

Radiation: External beam Radiotherapy

Interventions

External beam Radiotherapy RADIATION

Five fractions of radiation therapy using adaptive planning and CT or MRI guidance (6 Gy per fraction) delivered once every other day excluding weekends and holidays

Also known as: Hypofractionated External beam Radiotherapy

Hypofractionated External beam Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study considers endometrial and cervical cancer which are defined as physically occurring in the uterus and the cervix.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed endometrial or cervical cancer
• Surgical resection of the primary tumor
• International Federation of Gynecology and Obstetrics (FIGO) Stage IA-IVB endometrial cancer OR FIGO Stage IA-IIA cervical cancer that meets indications for receiving adjuvant pelvic radiotherapy alone as standard of care
• Age ≥ 18 years old
• Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) 0-2

You may not qualify if:

• Must not meet indications for receiving concurrent chemotherapy as standard of care
• Active treatment of a separate malignancy
• History of prior irradiation to the area to be treated

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Study Officials

• Puja S. Venkat, MD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Palodichuk

CONTACT

310-794-2971; cpalodichuk@mednet.ucla.edu

Vincent Basehart

CONTACT

310-267-8954; vbasehart@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, non-randomized, trial of adjuvant SBRT to the pelvis with adaptive planning using CT or MRI guidance for endometrial and cervical cancers

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 5, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): July 26, 2031
• Study Completion (Estimated): July 26, 2032
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (1)