Trial results for a study investigating a novel dose adjustment algorithm for preventing cytopenia-related delays during FOLFOX chemotherapy in patients with Colorectal Cancer and other gastrointestinal cancers were posted on ClinicalTrials.gov on 2025-10-06. The study enrolled 52 participants.
Background
Colorectal cancer is a significant global health concern, and chemotherapy regimens like FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) are commonly used for treatment. However, managing chemotherapy-induced side effects, particularly cytopenia, can lead to unplanned treatment delays or dose reductions. Such interruptions may compromise the overall efficacy of the chemotherapy. Interventions that can help maintain dose intensity while minimizing treatment delays are crucial for optimizing patient outcomes.
Trial design
This completed study, designated as Phase NA, enrolled 52 participants. The trial investigated a novel dose adjustment algorithm for preventing cytopenia-related delays during FOLFOX chemotherapy in patients with Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Ampullary Cancer, and Small Bowel Cancer. The primary objective was to evaluate the effectiveness of an investigator-developed chemotherapy dose adjustment algorithm for reducing unplanned delays in patients receiving FOLFOX-type chemotherapy, while maintaining acceptable chemotherapy dose-intensity.
Key results
The trial reported several key measurements:
- For "Unplanned Chemotherapy Treatment Delay" among evaluable participants, 16 participants experienced such delays.
- For the "Composite Safety Endpoint" among all enrolled participants, 3 participants met this endpoint.
- For "Relative Dose Intensity of Chemotherapy" among participants completing six cycles of FOLFOX, the mean values observed were 0.913, 0.850, and 0.643.
What this means
The posted results provide initial data on the performance of a novel dose adjustment algorithm for FOLFOX chemotherapy in patients with various gastrointestinal cancers. The study observed that 16 participants experienced unplanned treatment delays, and a composite safety endpoint was met by 3 participants. The reported mean relative dose intensities of 0.913, 0.850, and 0.643 for participants completing six cycles of FOLFOX offer insights into the algorithm's ability to maintain chemotherapy dose intensity. These findings contribute to understanding strategies for optimizing chemotherapy delivery and managing treatment-related complications.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04526886, titled "Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy", were posted on 2025-10-06 on clinicaltrials.gov.