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taTME Surgery for Rectal Cancer
Study Summary
This trial is a phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a history of inflammatory bowel disease.I can take care of myself but might not be able to do heavy physical work.My medical team agrees I can have minimally invasive rectal surgery.My cancer is at an early but high-risk or moderate stage without significant spread to nearby lymph nodes.It has been over 12 weeks since I finished my pre-surgery treatment.My tumor has spread into the internal anal muscle, confirmed by MRI.I have had colorectal cancer in the past.I am 18 years old or older.I have had surgery to remove part of my rectum.I have been newly diagnosed with rectal cancer.My recent colonoscopy showed no signs of additional colon cancer.My rectal cancer is within 10 cm of the anal opening.My CT scans show no signs of cancer spread.My MRI shows my cancer is at stage cT4.My rectal tumor causes severe symptoms.I experience loss of bowel control.You have an ongoing and uncontrolled illness.You are pregnant.
- Group 1: taTME
- 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
Is there still availability for recruits to join this medical experiment?
"Per the information provided by clinicaltrials.gov, this medical trial is actively seeking participants to begin enrollment. The first post was made on April 21st 2017 and the most recent modification occurred on April 6th 2022."
What is the current geographic scope of this clinical experiment?
"Patients can be recruited from Florida Hospital in Orlando, Mount Sinai Beth Israel in New york as well as Cleveland Clinic Florida located in Weston; these are only a few of the 13 other locations enrolling participants."
To what extent is participation in this research project currently being undertaken?
"Verified. According to the information accessible on clinicaltrials.gov, this study is presently in need of volunteers and has been since April 21st 2017. The trial requires 100 patients from 13 distinct medical centres before it can be completed and was recently updated on April 6th 2022."
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