Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of the study is to determine if neo-adjuvant FOLFOX therapy and lengthening the time interval between neo-adjuvant chemotherapy and transanal local excision will increase the percentage of patients with pathologic complete remission. This is a prospective pilot study to examine the impact of two variables: 1) addition of neo-adjuvant FOLFOX chemotherapy, and 2) increasing the time interval between completion of chemo-radiotherapy and subsequent surgery, on the rate of achieving pathologic complete remission with avoidance of radical resection while maintaining an excellent local control with improvement of quality of life. All procedures in this study are standard of care, the study question relates to the use of neo-adjuvant FOLFOX and the timing between the end of radiation and surgery.

Official Title
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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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Diagnosis of rectal invasive adenocarcinoma Tumor in the low or mid rectum (up to 11 cm from the anal verge) 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: Physical examination by the primary surgeon Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis Pelvic MRI and endoscopic ultrasound Exclusion Criteria: Less than 18 years of age Do not complete informed consent Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients in the trial receive the intervention and are followed prospectively.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neoadjuvant Chemotherapy and Follow-up Surgery<br>All patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response. | Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery<br>* All treatments (chemotherapy, radiation, surgery) are standard of care; however, the timing of the procedures is altered to allow for the possibility of local excision instead of more extensive surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission | Percent of patients who achieve complete remission | 18 months | 
| Partial remission | Percent of patients who achieve partial remission | 18 months | 
| Disease progression | Percent of patients with disease progression | 18 months | 
| Local resection | Percent of patients who require local resection only | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient quality of life | Quality of life score on questionnaire | 18 months | 
| Patient health status | Patient self-reported health status | 18 months |