Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers
NCT Number: NCT06538337
Acronym: HERA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometrial Cancer|Cervical Cancer
Interventions: RADIATION: External beam Radiotherapy
Sponsor: Jonsson Comprehensive Cancer Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2032-07-26
Locations: University of California at Los Angeles, Los Angeles, California, 90095, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30), Evaluate patient-reported quality-of-life scores using European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ) C30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item instrument designed to assess various aspects of the overall quality of life in patients with cancer. We will collect data pre-treatment and 3, 6-, 12-, 18-, and 24-months post-treatment.

The EORTC QLQ-C30 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much.

A higher score indicates worse quality of life., 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), Evaluate patient-reported quality-of-life scores using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). The EORTC QLQ-EN24 is a 24-item instrument designed to assess various aspects of treatment-related quality of life specifically in patients undergoing treatment for endometrial cancer. We will collect data pre-treatment and 3, 6-, 12-, 18-, and 24-months post-treatment.

The EORTC QLQ-EN24 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much.

A higher score indicates worse quality of life., treatment to 24 weeks after completion of radiotherapy|Evaluate late toxicity, Evaluate late toxicity according to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0). Late toxicity is defined as treatment-related adverse events occurring more than 12 weeks after completion of radiotherapy., 12 weeks after completion of radiotherapy until 5 years after completion of radiotherapy|Evaluate local control, Evaluating control of the treated tumor. Local control will be estimated using Kaplan-Meier analysis at 5 years., treatment to 5 years after completion of radiotherapy|Evaluate regional control, Evaluating control of disease within the abdomen and pelvis. Regional control will be estimated using Kaplan-Meier analysis at 5 years., treatment to 5 years after completion of radiotherapy|Evaluate distant metastasis, Evaluating the spread of the disease to distant sites. Distant metastasis will be estimated using Kaplan-Meier analysis at 5 years., treatment to 5 years after completion of radiotherapy|Evaluate progression-free survival, Evaluating patient survival free from any disease progression (local, regional, or distant). Progression-free survival will be estimated using Kaplan-Meier analysis at 5 years., treatment to 5 years after completion of radiotherapy