Status:
RECRUITING
Ultra-fractionated Radiotherapy for Rectal Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 radiatio...
Detailed Description
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated adaptive RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX (5-FU, oxaliplatin, leucovorin) or...
Eligibility Criteria
Inclusion
- 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:
- WBC ≥ 3,000/mL;
- ANC WBC ≥ 1,000/mL;
- PLT ≥ 75,000/mL;
- T Bili ≤ 1.5 x upper limit of normal (ULN);
- AST/ALT ≤ 2.5 x ULN;
- Creatinine not above ULN, or creatinine clearance \>50 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal.
- 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.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04677413
Start Date
June 3 2021
End Date
June 1 2026
Last Update
April 18 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8849