NCT06538337 Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers
| NCT ID | NCT06538337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-24 |
| Primary Completion | 2031-07-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-07-24 with a primary completion date of 2031-07-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Puja S. Venkat, MD
PRINCIPAL INVESTIGATOR
University of California at Los Angeles
Frequently Asked Questions
Who can join the NCT06538337 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06538337 currently recruiting?
Yes, NCT06538337 is actively recruiting participants. Contact the research team at cpalodichuk@mednet.ucla.edu for enrollment information.
Where is the NCT06538337 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06538337 clinical trial?
NCT06538337 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Puja S. Venkat, MD at University of California at Los Angeles. The trial plans to enroll 60 participants.
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