Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJonsson Comprehensive Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
External beam Radiotherapy
RadiationFive 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
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Hypofractionated External beam RadiotherapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
treatment to 12 weeks after completion of radiotherapySecondary outcomes
1
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.
Time frame
treatment to 24 weeks after completion of radiotherapy2
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.
Time frame
treatment to 24 weeks after completion of radiotherapy3
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.
Time frame
12 weeks after completion of radiotherapy until 5 years after completion of radiotherapy4
Evaluate local control
Evaluating control of the treated tumor. Local control will be estimated using Kaplan-Meier analysis at 5 years.
Time frame
treatment to 5 years after completion of radiotherapySponsors and contacts
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Source ClinicalTrials.gov