Shorter treatment duration with new therapy is focus of rectal cancer trial
Colorectal cancer is the second most frequent cause of cancer deaths in the United States, and a growing number of younger people are diagnosed with the disease. Since the 1990s, the rate of colorectal cancer in adults younger than 50 has been rising while the rate in older adults is declining, in part due to screening.
Rectal cancer develops in the last 12 centimeters of the large intestine and is uniquely challenging to treat because of its location near the anus and other major organs. There are different ways to treat this disease, but the six most common treatments include:
Some of these treatments are combined, such as surgery with radiation therapy and chemotherapy before or after surgery.
While existing approaches can be successful at treating rectal cancer and afford people longer lives without cancer, the side effects can greatly affect quality of life. For example, if the cancer has spread to other organs near the rectum, larger surgery is required and if the cancer is too close to the anus, a permanent colostomy may be necessary.
Clinical trials help improve treatments and outcomes
Clinical trials provide an opportunity to improve current treatment options for rectal cancer patients. For some people, participating in a trial may be the best treatment available.
A new clinical trial at Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon, will evaluate the safety and efficacy of a short-course radiation and chemotherapy treatment in advance of surgery for people with stage II/III rectal cancer. The study is known as SHORT and can be found on ClinicalTrials.gov: NCT04417699.
Patients enrolled in this phase II trial receive five days of radiation followed by three months of chemotherapy with six cycles of TASOX, which is a combination of TAS-102 and Oxaliplatin. TAS-102 (Lonsurf®) is FDA approved for the treatment of advanced colorectal. The trial is among the first to use TAS-102 in earlier stage (stage II/III) colorectal cancer and aims to determine its effectiveness as a treatment. In an international clinical trial, TAS-102 showed improved outcomes in patients with metastatic colorectal cancer.
Oxaliplatin is approved to be used with other drugs to treat advanced colorectal cancer and stage II/III colon cancer.
“Minimizing the duration and using a new cancer therapy are the key components of this trial,” says Hagen Kennecke, M.D., MHA, FRCPC, medical oncologist and medical director of gastrointestinal oncology at Providence Cancer Institute. Dr. Kennecke is the principal investigator of the study.
Following TASOX treatment, eligible patients will undergo a surgical procedure called a total mesorectal excision (TME) to remove the remaining cancer.
Giving therapies to patients before surgery, called neoadjuvant treatment, improve the chances of removing the cancer during surgery, especially if the size or location of the tumor makes it difficult to access and remove.
Trial participants receive only neoadjuvant therapy but no further treatment after surgery. Dr. Kennecke says this may be better for the patients because chemotherapy and/or radiation before surgery is known to be more effective and have fewer side effects.
“The advantage of treating the tumor earlier is that by the time you do surgery you can see how well the treatment worked,” says Dr. Kennecke. “That’s a marker of how successful a treatment is. In this case, we hope to see our patients’ tumors completely disappear.”
Trial open to patients with operable rectal cancer
Providence Cancer Institute is co-sponsor of this trial with Taiho Oncology. The trial is currently recruiting patients in the U.S. Criteria for eligibility includes but is not limited to patients with:
Newly diagnosed rectal adenocarcinoma
A tumor that has not metastasized
The tumor is surgically removable
Clinical stage cancer diagnosis of T1/N1, T2/N1, T3/N1, T3N0
Read more about the trial here:
To find out more about other clinical trials at Providence Cancer Institute or to refer a patient, contact our clinical research office:
New research studies are added on a regular basis. To view more clinical studies, visit our website:
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National standard of excellence for rectal cancer care
In June 2021, Providence Cancer Institute’s Rectal Cancer Program earned accreditation from the National Accreditation Program for Rectal Cancer (NAPRC). Providence Portland and Providence St. Vincent medical centers were the first in the Pacific Northwest and among the first 25 in the nation to earn this honor. Programs that receive accreditation provide specialized treatment by a multidisciplinary team that has shown to improve patient outcomes. For patients with rectal cancer, that means lower rates of cancer recurrence, lower rates of requiring a permanent colostomy, and better long-term survival.