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Radiation
Ultra-fractionated Radiotherapy for Rectal Cancer
Phase 1
Recruiting
Led By Nina Sanford, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T3-4 and/or N+ disease per AJCC 8th edition
Pathologic diagnosis of rectal adenocarcinoma
Must not have
Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
Prior RT to the pelvis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to treat rectal cancer that may be more effective than current methods.
Who is the study for?
Adults with locally advanced rectal cancer who haven't had previous treatment for it. They must have good organ and bone marrow function, no distant nodal or metastatic disease, and a stable health condition without severe psychiatric illness. Participants need to agree to use contraception during the trial.
What is being tested?
The trial is testing a new approach called ultra-fractionated radiotherapy combined with chemotherapy in patients with rectal cancer. The goal is to see if this method allows for better control of the disease without surgery.
What are the potential side effects?
Potential side effects may include skin irritation, fatigue, nausea, diarrhea from radiation; plus additional risks from chemotherapy like lowered blood counts leading to infection risk, bruising or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at a stage where it has grown into surrounding tissues or spread to nearby lymph nodes.
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I have been diagnosed with rectal cancer.
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My kidney function is within normal limits.
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My recent blood tests show my organs are functioning well.
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I am able to get out of my bed or chair and move around.
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I have not received any treatment for rectal cancer.
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I have not had my uterus or both ovaries removed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any severe illnesses like heart failure or mental health issues that would stop me from following the study's requirements.
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I have had radiation therapy to my pelvic area before.
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My cancer has spread to distant lymph nodes or other areas, confirmed by CT.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.
Secondary study objectives
For patients undergoing surgery, to evaluate the rate of R0 resection, defined as a negative surgical margin at time of total mesorectal excision.
Pharmacotherapy
Disease
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase I Dose CohortsExperimental Treatment1 Intervention
DOSE LEVEL 1 : 30 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 2 : 35 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 3 : 40 Gy (tumor)/ 25 Gy (pelvis)
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,162 Total Patients Enrolled
Nina Sanford, MD1.01 ReviewsPrincipal Investigator - UT SOUTHWESTERN medical CENTRE
University of Texas Southwestern Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is at a stage where it has grown into surrounding tissues or spread to nearby lymph nodes.I have been diagnosed with rectal cancer.My kidney function is within normal limits.My recent blood tests show my organs are functioning well.I do not have any severe illnesses like heart failure or mental health issues that would stop me from following the study's requirements.I am a woman who can still have children and have not been through menopause.I am a woman capable of becoming pregnant.I am able to get out of my bed or chair and move around.I have had radiation therapy to my pelvic area before.I am 18 years old or older.I have not received any treatment for rectal cancer.My cancer has spread to distant lymph nodes or other areas, confirmed by CT.I have not had my uterus or both ovaries removed.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Dose Cohorts
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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