New alliance trial seeks to reduce delays in gastrointestinal cancer treatment

To make cancer care smoother and more effective, the Alliance for Clinical Trials in Oncology has introduced a new clinical trial for people with gastrointestinal cancers, such as cancers of the stomach, colon, and esophagus. The PAGODA trial (Alliance A232402CD) will test a proactive approach to chemotherapy dose adjustments, aiming to minimize treatment interruptions and help patients complete their chemotherapy as planned.

“Unplanned chemotherapy interruptions can be stressful, time consuming, and may affect how well treatment works,” said study chair Gabriel Brooks, MD, MPH, an Associate Professor of Medicine at the Dartmouth Geisel School of Medicine. “Our trial will test a new approach that uses a clear, step-by-step plan to adjust chemotherapy doses before problems occur rather than waiting until side effects happen.”

While some treatment delays are necessary due to new or worsening medical problems, many delays are triggered by asymptomatic changes that are only found in routine blood work. These unplanned delays are disruptive for patients and their caregivers because they lead to additional travel, blood draws, clinic visits, and time away 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 duplicative future clinic visits and laboratory testing. Lastly, delays that lead to reduced chemotherapy dose-intensity can have a negative effect on cancer treatment outcomes 

This trial will test PAGODA, the Proactive Graduated Dose Modification Algorithm. It’s a structured plan that helps doctors make small, proactive changes to chemotherapy doses to prevent treatment delays. Instead of reacting after severe side effects occur, PAGODA guides doctors to act early, keeping patients on schedule and reducing stress and delays.

The trial plans to enroll about 400 patients with cancer of the esophagus, gastroesophageal junction, stomach, small intestine, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin. Participants will be randomly assigned to one of two groups:

o        Standard Care: Doctors adjust chemotherapy doses as they normally would.

o        PAGODA Approach: Doctors follow the algorithm to guide dose changes.

Both groups receive the same chemotherapy drugs commonly used for GI cancers.

"This study is about improving experience for patients and their loved ones,” added Dr. Brooks. “We want to reduce the uncertainty and interruptions that come with traditional dosing methods and give patients a smoother, more predictable treatment journey. If PAGODA proves successful, it could change how we manage chemotherapy for gastrointestinal cancers—making care more consistent and less burdensome.”

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Reference: Alliance A232402CD/NCT07283939 - PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays

The Alliance for Clinical Trials in Oncology is a national leader in advancing cancer research, uniting more than 25,000 cancer specialists at 115 main institutions and 1,400 affiliates across the U.S. and Canada. As part of the National Clinical Trials Network and a leading research base for the NCI Community Oncology Research Program, the Alliance conducts pioneering, practice-changing clinical trials that improve outcomes and reshape standards of care. Its work has led to multiple FDA approvals, influenced national guidelines, and produced hundreds of high-impact publications. More than 40,000 participants have taken part in Alliance studies, and its growing biospecimen repository now includes more than 1.5 million samples, collected over the past 30 years. Learn more at www.AllianceforClinicalTrialsinOncology.org.

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