Organ Preservation for Rectal Cancer Study Continues Following Patients
The first prospective study to investigate feasibility of non-operative management of rectal cancer patients who have a complete response to neoadjuvant therapy is closed to accrual, but patients continue to be followed long term.
CHI Health Creighton University Medical Center - Bergan Mercy is one of 25 locations involved in the study coordinated by Memorial Sloan Kettering and the national Rectal Cancer Consortium.
“We hope to determine three- and five-year survival with total neoadjuvant chemotherapy and radiation for locally advanced rectal cancer and the option of not removing the rectum if patients have a significant clinical response,” said Charles Ternent, MD, CHI Health colorectal surgeon. “The goal is to preserve the rectum if possible and then monitor for regrowth without having to undergo surgery. The option of avoiding surgery and a radical resection of the rectum is appealing for excellent responders because of the potential benefits in quality of life by not having a stoma and by avoiding the risks and changes in bowel function associated with radical rectal surgery.”
Study candidates had a histologically confirmed diagnosis of adenocarcinoma of the rectum, clinical Stage II (T3- 4, N-) or Stage III (any T, N+) based on MRI, rectal tumor at baseline which would be considered to require total mesorectal excision (TME), no evidence of distant metastases, no prior pelvic radiation therapy and no prior chemotherapy or surgery for rectal cancer.
Rodney Rihner of Harlan, Iowa, was enrolled in the study after being diagnosed with rectal cancer in 2016. He completed chemotherapy and radiation in 2017. “It was to me a Godsend that surgery was unnecessary,” he said.
Rihner will return for follow-up every three months for two years, and every six months for the next three years.
“I feel safe without having the surgery because they watch me closely. I guess that’s why they do the clinical trials,” he said. “If it can help someone else down the line, that’s a good thing.”
Rihner is one of nine patients actively enrolled in the study at CHI Health.