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Off-Protocol Radiation Therapy in Phase 3 Metastatic Solid Tumor Trials.

Alexander D Sherry¹, Timothy A Lin², Zachary R McCaw³

¹Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

International Journal of Radiation Oncology, Biology, Physics

|October 1, 2024

Summary

Most phase 3 trials permit off-protocol radiation therapy, but its impact on systemic therapy outcomes is understudied. Few trials report utilization, and those allowing it may be more likely to meet primary endpoints.

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Area of Science:

Oncology
Clinical Trials
Radiation Oncology

Background:

Radiation therapy, especially ablative radiation therapy, may alter the course of metastatic disease.
Off-protocol radiation therapy in systemic therapy trials can potentially influence study endpoints.

Purpose of the Study:

To determine the frequency of off-protocol radiation therapy allowance and utilization in phase 3 systemic therapy trials.
To investigate the correlation between off-protocol radiation therapy and study outcomes.

Main Methods:

Screened 112 two-arm, superiority-design, phase 3 randomized trials from ClinicalTrials.gov (2010-2019).
Assessed trial protocols for off-protocol radiation therapy policies.
Used logistic regression to calculate adjusted odds ratios for outcome correlation.

Main Results:

Off-protocol radiation therapy was allowed in 52% of trials, not discussed in 25%, and prohibited in 23%.
Only 2% of trials reported utilization rates; ablative radiation therapy use was not detailed.
Trials permitting off-protocol radiation therapy were more likely to meet primary endpoints in open-label studies (aOR, 4.50).

Conclusions:

Most phase 3 systemic therapy trials allow off-protocol radiation therapy.
The influence of off-protocol radiation therapy, particularly ablative forms, on study outcomes remains largely unevaluated.