Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03941366|
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients in the trial receive the intervention and are followed prospectively.|
|Masking:||None (Open Label)|
|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|
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.
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
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, BAfirstname.lastname@example.org|
|Contact: Susan M Szpunar, PhDemail@example.com|
|United States, Michigan|
|Ascension St. John Hospital||Recruiting|
|Detroit, Michigan, United States, 48236|
|Contact: Lisa C. Miller, BA 313-343-3166 firstname.lastname@example.org|
|Contact: Amr Aref, MD 313-343-3166 email@example.com|