An interventional study of Standard of care chemotherapy with the change for avoidance of extensive surgery in Rectal Cancer, sponsored by Henry Ford Health System. Terminated at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 15 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
1. Clinical staging will be estimated based on the combination of the following assessments:
Exclusion Criteria:
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
Percent of patients who achieve complete remission
Time frame: 18 months
Partial remission
Percent of patients who achieve partial remission
Time frame: 18 months
Disease progression
Percent of patients with disease progression
Time frame: 18 months
Local resection
Percent of patients who require local resection only
Time frame: 18 months
Patient quality of life
Quality of life score on questionnaire
Time frame: 18 months
Patient health status
Patient self-reported health status
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Henry Ford Health System