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Chemoradiation for Rectal Cancer (SMART TNT Trial)
SMART TNT Trial Summary
This trial is testing whether it's safe and effective to give chemotherapy to patients with locally advanced rectal cancer before radiation therapy, and whether a higher dose of radiation therapy can help patients avoid surgery.
SMART TNT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSMART TNT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 940 Patients • NCT00265941SMART TNT Trial Design
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- My tumor is within 18 cm of the anal verge.I have had radiation therapy in the pelvic area before.I have been recently diagnosed with rectal cancer.I do not have severe infections needing IV antibiotics or active TB.I am 18 years old or older.I do not have metal implants, a pacemaker, or severe claustrophobia.I have moderate to severe numbness, tingling, or muscle weakness.I have been approved for intensive chemo before surgery by a team of cancer doctors.My primary tumor is classified as T3N0 or has positive nodes based on MRI.I am able to care for myself and perform daily activities.I have not had any cancer other than non-spreading skin cancer in the last 5 years.My initial scans showed cancer has spread to other parts of my body.I do not have severe heart failure, recent heart attacks, or uncontrolled heart rhythm problems.
- Group 1: SMART TNT Plan I
- Group 2: SMART TNT Plan II
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Have regulatory bodies granted their seal of approval to Intensity-modulated radiation therapy?
"Assessing Intensity-modulated radiation therapy, our team at Power judged its safety to be a 1 due to the restricted amount of data indicating efficacy and security in this Phase 1 trial."
Is it still possible to register for this particular research study?
"This particular clinical trial is currently seeking participants, with the initial posting on October 5th 2022. As of October 28th 2022, no changes have been made to the study's design."
What is the limit of eligible participants in this medical trial?
"Affirmative. Documentation on clinicaltrials.gov states that this medical experiment, initiated on October 5th 2022, is actively accepting participants. 25 patients are desired from a single site for the duration of the trial."
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