Actively Recruiting
Ultra-fractionated Radiotherapy for Rectal Cancer
Led by University of Texas Southwestern Medical Center · Updated on 2026-04-27
27
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultra-fractionated Radiotherapy for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Able and willing to provide written informed consent
- Pathologic diagnosis of rectal adenocarcinoma
- T3-4 and/or N+ disease according to AJCC 8th edition
- No prior treatment for rectal adenocarcinoma
- Eastern Cooperative Group (ECOG) performance status of 0-2
- Laboratory values within acceptable limits for organ and marrow function within 30 days prior, including:
- WBC 3,000/mL
- ANC WBC 1,000/mL
- Platelets 75,000/mL
- Total bilirubin 1.5 times upper limit of normal
- AST/ALT 2.5 times upper limit of normal
- Creatinine at or below upper limit of normal, or creatinine clearance above 50 mL/min/1.73 m2 if above institutional normal
- Men and women of child-bearing potential must agree to use effective contraception from first dose through 90 days after last dose
- Women of child-bearing potential defined as those who have not had hysterectomy or bilateral oophorectomy, or have had menses in past 12 months
You will not qualify if you...
- Presence of distant nodal disease including retroperitoneal or inguinal nodes or any metastatic disease by CT
- Prior radiation therapy to the pelvis
- Uncontrolled comorbid illnesses such as congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting study compliance
- Psychiatric illness or social situations limiting ability to consent or comply with study
- Pregnancy or nursing due to risk of congenital abnormalities and potential harm to infants
AI-Screening
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Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8849
Actively Recruiting
Research Team
B
Busayo Adefalujo
CONTACT
S
Sarah Neufeld
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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