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Terminated
NCT03941366
Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders
Conditions: Rectal Cancer
Sex: All
Ages: 18 Years – 95 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Henry Ford Health System
Location: Ascension St. John Hospital Detroit Michigan
Summary
The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. Diagnosis of rectal invasive adenocarcinoma
3. Tumor in the low or mid rectum (up to 11 cm from the anal verge)
4. Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible.
1\. Clinical staging will be estimated based on the combination of the following assessments:
1. Physical examination by the primary surgeon
2. Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis
3. Pelvic MRI and endoscopic ultrasound
Exclusion Criteria:
* Less than 18 years of age
* Do not complete informed consent
* Pregnant women
Source: ClinicalTrials.gov (NCT03941366). StuddyBuddy aggregates publicly available trial information.