Clinical Trials Seek Surgical Options for Patients with Colorectal, Bowel Obstruction and Esophageal Cancers

In 2018, an estimated 1,735,350 new cancer cases were diagnosed in the U.S. Of those, 609,640 people died from the disease.* Clinical trials in surgical oncology at The University of Kansas Cancer Center seek to discover new ways to reduce those numbers and save lives.

Surgical trials are challenging to conduct in any institution because it is difficult to blind patients to different surgical techniques. However, because the cancer center is part of a large, academic medical center with a high volume of patients and a National Cancer Institute designation, we have several leading-edge surgical oncology trials underway. They focus on developing treatment options that bring more possibilities to patients battling colorectal, bowel obstruction and esophageal cancers.

Radiation oncologist Christopher Lominska, MD, is leading a trial that uses chemotherapy and chemoradiation with investigational agents to help resect patients with rectal cancers. The study compares rates of exosomal expression before, during and after chemoradiation therapy with pathologic response rates at the time of abdominoperineal resection or low anterior resection.

The primary goal is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer who are undergoing neoadjuvant chemoradiation therapy. To participate, patients must:

• Be 18 or older
• Have a historically proven diagnosis of rectal adenocarcinoma
• Receive neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection

We also have ongoing clinical trials that complement the resection itself and administer adjuvant chemotherapy after the patient has had a resection.

Our phase II cytoreductive surgery-hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) trial compares debulking tumors with 2 chemotherapy agents administered with an intraperitoneal infusion. My colleague, Mazin Al-kasspooles, MD, is leading the trial.

CRS-HIPEC, long considered standard treatment for ruptured appendiceal neoplasms and primary peritoneal mesothelioma, is now being used to treat tumor deposits along the inside abdominal or pelvic wall and surfaces of the intestines and organs. When combined with cytoreductive surgery, HIPEC can improve outcomes for patients with advanced, complex and recurrent abdominal and primary peritoneal cancers and select ovarian cancers.

HIPEC is a surgical procedure that removes all visible tumors from the abdomen. It then delivers heated chemotherapy directly inside the abdomen to help destroy any unseen microscopic cancer cells and tumors. The goal of HIPEC is to prevent cancer cells from growing into new tumors and allowing the cancer to return.

To be included in the trial, patients must:

• Be 18-75 years old
• Have peritoneal surface disease due to colorectal cancer or high-grade appendiceal cancer
• Have no clear evidence of systemic metastases
• Have had no prior CRS-HIPEC treatment
• Have a planned complete macroscopic cytoreduction

Malignant bowel obstruction is a common problem for advanced cancer patients, especially in those with abdominal tumors. However, it is not yet known if surgery or nonsurgical management is the best option for treating malignant bowel obstruction and improving quality of life. We have partnered with the Southwest Oncology Group in a phase III clinic trial that seeks to answer that question.

The Southwest Oncology Group Research Network has more than 1,000 member institutions, including The University of Kansas Cancer Center. Members reflect the full spectrum of professionals who design and conduct cancer trials: physicians, nurse oncologists, clinical research associates, statisticians, scientists, patient advocates and pharmacists.

Criteria for patient participation includes:

• Clinical evidence of a malignant bowel obstruction due to an intra-abdominal primary cancer
• Ability to tolerate a major surgical procedure
• A member of the patient’s surgical team must indicate equipoise

In this phase II trial, my colleague, hematology/oncology specialist Weijing Sun, MD, principal investigator, is evaluating the efficacy and safety of a perioperative chemotherapy and immunotherapy combination regimen in participants with potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) and stomach.

Patients may qualify for this trial if they:

• Are age 18-75
• Have histologically or cytologically confirmed diagnosis of adenocarcinoma of the GEJ or stomach
• Have newly diagnosed localized or locally advanced, potentially resectable disease without any prior systemic chemotherapy
• Have no evidence of distant metastases
• Are eligible and reasonably fit to undergo potentially curative resection

We are actively recruiting patients for these trials. Participants in clinical trials at the cancer center receive the standard of care and aggressive surgical expertise while helping to further the field of cancer treatment.

*Statistics according to the National Cancer Institute.

Dr. Al-Rajabi specializes in gastrointestinal cancers. His clinical practice is focused on liver cancer, bile duct cancer, carcinoid tumors, colorectal cancer and GI cancer drug development. He is board-certified in internal medicine, medical oncology and hematology.