Rectal Cancer Clinical Trial
Official title:
Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (5FU/Capecitabine)-Radio Therapy (CRT) With Transanal Local Excision for Complete Responders
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ascension St. John Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Ascension South East Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete remission | Percent of patients who achieve complete remission | 18 months | |
Primary | Partial remission | Percent of patients who achieve partial remission | 18 months | |
Primary | Disease progression | Percent of patients with disease progression | 18 months | |
Primary | Local resection | Percent of patients who require local resection only | 18 months | |
Secondary | Patient quality of life | Quality of life score on questionnaire | 18 months | |
Secondary | Patient health status | Patient self-reported health status | 18 months |
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