Alliance study tests proactive dose adjustments of chemotherapy in gastrointestinal cancer

Alliance study tests proactive dose adjustments of chemotherapy in gastrointestinal cancer

To make cancer treatment smoother and more effective, the Alliance for Clinical Trials in Oncology has launched a new clinical trial for people with gastrointestinal cancers, such as stomach, colon and esophageal cancer. The PAGODA trial (Alliance A232402CD) is testing a proactive chemotherapy dose adjustment approach aimed at minimizing treatment interruptions and helping patients complete their chemotherapy as planned.

Unplanned interruptions to chemotherapy can be stressful and time-consuming and can affect the success of the treatment. Our study will test a new approach that uses a clear, step-by-step plan to adjust chemotherapy doses before problems arise, rather than waiting until side effects occur.”

Gabriel Brooks, MD, MPH, Principal Investigator, Associate Professor of Medicine, Dartmouth Geisel School of Medicine

While some treatment delays are necessary because of new or worsening medical problems, many delays are caused by asymptomatic changes that are only found on routine blood tests. These unplanned delays are disruptive to patients and their caregivers, resulting in additional travel, blood draws, clinic visits, and absences from home and work—a phenomenon increasingly recognized as time toxicity.

Unplanned delays are also inefficient for clinical teams, resulting in unused treatment capacity at the time of the delay and duplicate clinic visits and laboratory tests in the future. Finally, delays resulting in reduced chemotherapy dose intensity may negatively impact cancer treatment outcomes

This study tests PAGODA, the proactive graded dose modification algorithm. This is a structured plan that helps doctors make small, proactive changes to chemotherapy dosage to prevent treatment delays. Instead of reacting after serious side effects occur, PAGODA guides physicians to act early, keeping patients on schedule and reducing stress and delays.

The study will enroll approximately 400 patients with cancers of the esophagus, gastroesophageal junction, stomach, small intestine, appendix, colon and rectum, as well as cancers of unknown origin with suspected GI origin. Participants will be randomly assigned to one of two groups:

OStandard care:Doctors adjust chemotherapy doses as usual.

OPAGODA approach:Doctors follow the algorithm to guide dosage changes.

Both groups will receive the same chemotherapy drugs commonly used for gastrointestinal cancer.

“This study is about improving the experience for patients and their families,” added Dr. Brooks added. "We want to reduce the uncertainty and disruption associated with traditional dosing methods and provide patients with a smoother and more predictable course of treatment. If PAGODA proves successful, it could change the way we treat chemotherapy for gastrointestinal cancer, making treatment more consistent and less burdensome."

Sources: