Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vermont Medical Center
About this trial
This is a prospective single-center single-arm Phase II trial of HART for patients with metastatic cancer. The primary objective is to assess the incidence of acute GI toxicity following HART. PRO-CTCAE GI scores observed in the study patients will be compared to historical rates. Secondary outcomes include measuring changes in health-related quality of life, esophageal quality of life, toxicity, dosimetric outcomes, and pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Hybrid Palliative Radiation Therapy
RadiationHybrid Palliative Radiation Therapy will be administered to all patients.
Treatment groups
103 Participants
are divided into 1 treatment groupGroup A: Hybrid Arc Palliative Radiation TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of acute gastrointestinal (GI) toxicity
Th incidence of acute gastrointestinal (GI) toxicity (defined as a score of ≥2) at 4 weeks post-treatment initiation will be measured and compared to historical data, using PRO-CTCAE GI scores to determine if HART reduces GI toxicity.
Time frame
4 weeksSecondary outcomes
1
patient-reported health-related quality of life
Changes in patient-reported health-related quality of life (HRQOL) following HART treatment will be measured, as assessed by the EORTC QLQ-C15-PAL questionnaire from baseline measurements.
Time frame
4 weeks2
patient-reported esophageal quality of life
To assess changes in patient-reported esophageal quality of life (QOL) following HART, as measured by the Esophageal Cancer Subscale (ECS) of the FACT-E for thoracic disease, from baseline measurements.
Time frame
4 weeks3
physician graded toxicity
Assess physician graded toxicity using NCI-CTCAE v5.
Time frame
4 weeks4
dosimetric outcomes of HART
To compare the dosimetric outcomes of HART and conventional AP/PA plans by analyzing dose-volume histograms, with a specific focus on the gastrointestinal organs at risk.
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov