Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders
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ClinicalTrials.gov Identifier: NCT03941366 |
Recruitment Status :
Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
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Condition or disease | Intervention/treatment | Phase |
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Rectal Cancer | Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All patients in the trial receive the intervention and are followed prospectively. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 26, 2016 |
Estimated Primary Completion Date : | January 1, 2025 |
Estimated Study Completion Date : | January 1, 2025 |
Arm | Intervention/treatment |
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Neoadjuvant Chemotherapy and Follow-up Surgery
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.
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Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery
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. |
- Complete remission [ Time Frame: 18 months ]Percent of patients who achieve complete remission
- Partial remission [ Time Frame: 18 months ]Percent of patients who achieve partial remission
- Disease progression [ Time Frame: 18 months ]Percent of patients with disease progression
- Local resection [ Time Frame: 18 months ]Percent of patients who require local resection only
- Patient quality of life [ Time Frame: 18 months ]Quality of life score on questionnaire
- Patient health status [ Time Frame: 18 months ]Patient self-reported health status

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Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941366
Contact: Lisa C Miller, BA | 313-343-3166 | lisa.miller4@ascension.org | |
Contact: Susan M Szpunar, PhD | 313-343-7838 | susan.szpunar@ascension.org |
United States, Michigan | |
Ascension St. John Hospital | Recruiting |
Detroit, Michigan, United States, 48236 | |
Contact: Lisa C. Miller, BA 313-343-3166 lisa.miller@ascension.org | |
Contact: Amr Aref, MD 313-343-3166 amr.aref@ascension.org |
Responsible Party: | Amr Aref, Director, Radiation Oncology, Ascension South East Michigan |
ClinicalTrials.gov Identifier: | NCT03941366 |
Other Study ID Numbers: |
866142 |
First Posted: | May 7, 2019 Key Record Dates |
Last Update Posted: | May 7, 2019 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |