Ultra-fractionated Radiotherapy for Rectal Cancer (NCT04677413) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Ultra-fractionated Radiotherapy for Rectal Cancer
United States27 participantsStarted 2021-06-03
Plain-language summary
The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.
Who can participate
Age range
18 Years
Sex
ALL
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
. At least 18 years of age. Both men and women and members of all races and ethnic groups will be included.
. Willing and able to provide written informed consent
. Pathologic diagnosis of rectal adenocarcinoma
. T3-4 and/or N+ disease per AJCC 8th edition
. No prior treatment for rectal adenocarcinoma
. Eastern Cooperative Group (ECOG) performance status of 0-2.
. Laboratory values supporting acceptable organ and marrow function within 30 days of eligibility confirmation. Defined as follows:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.
Timeframe: 0 to 60 days post radiation therapy
Trial details
NCT IDNCT04677413
SponsorUniversity of Texas Southwestern Medical Center
. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of study therapy through 90 days after the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion criteria
. Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT.
. Prior RT to the pelvis.
. Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
. Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
. Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants