Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial (NCT06778408) | Clinical Trial Compass
RecruitingPhase 2
Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial
United States103 participantsStarted 2025-04-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Histological confirmation of cancer with radiographic (CT, MRI or PET) evidence of metastatic disease
Palliative radiotherapy indicated for bone or soft tissue metastases, or primary targets, located in the thorax, abdomen, or pelvis as part of their standard of care treatment plan
Age ā„ 18 years.
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
In lieu of a pregnancy test, participants may sign the Pregnancy Attestation Form, a standard form routinely used in clinical practice at UVMCC.
Recommended methods of birth control are:
The consistent use of an approved hormonal contraception (birth control pill/patches, rings), An intrauterine device (IUD), Contraceptive injection (Depo-Provera), Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), Sexual abstinence (no sexual intercourse) or Sterilization.
Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteriā¦