SABR Protocol Deviations Linked to Poorer Survival in Oligometastatic Head and Neck CancerMajor protocol deviations cut survival time for head and neck cancer patients

International journal of radiation oncology, biology, physics Published May 1, 2026 Study authors: Maury Pauline, Sayous Yann, Marnaoui Ryan, Loiseau Cédric, Khalladi Nazim, Sun Xu-Shan, Bourhis Jean… PubMed ↗ DOI ↗ Editorial oversight: Dr. Lars van Dijk, PhD · Surgical, Procedural & Diagnostic

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Key Takeaway

Consider that major SABR protocol deviations are associated with poorer survival in oligometastatic head and neck cancer, highlighting the need for rigorous quality assurance.

This exploratory analysis of the randomized phase 2 GORTEC 2014-04 trial evaluated the impact of protocol deviations in multisite stereotactic ablative body radiation therapy (SABR) on survival outcomes in patients with oligometastatic head and neck cancer. The study included 69 patients with 98 metastases, with a median follow-up of 55.3 months.

Patients were categorized by deviation status: 19 without deviation, 36 with at least a minor deviation, and 12 with at least a major deviation. Median overall survival was 61.7 months (IQR, 41.1-Not reached) in patients without deviation, 50.9 months (IQR, 32.1-Not reached) in those with minor deviations, and 20.9 months (IQR, 12.1-81.7) in those with major deviations. The association between major deviations and poorer survival was statistically significant (P < .001 for conformity number; P = .01 for modified gradient index).

Safety and tolerability data were not reported. Major deviations were mostly related to cumulative size of oligometastases and organ-at-risk proximity. The analysis is exploratory and based on quantitative dosimetric indices, so causality cannot be inferred.

Clinicians should recognize that protocol deviations in SABR, particularly major ones, may be associated with worse survival. Quality assurance measures, such as individual case review, may help reduce deviations and improve outcomes.

Patients with oligometastatic head and neck cancer received focused radiation therapy. The goal was to destroy cancer cells while sparing healthy tissue. Ninety-eight metastases were treated across sixty-nine patients. The team compared outcomes between those who followed the plan exactly and those with errors. Quality assurance reviews caught mistakes before they hurt patients. This review of the GORTEC 2014-04 trial looked at survival data after a median follow-up of fifty-five months. The median time lived was sixty-one months for those without errors. It dropped to fifty-one months with minor mistakes and twenty-one months with major ones. Major deviations mostly involved treating larger cancer clusters or areas near sensitive organs. These errors were linked to shorter survival times. The study found a strong connection between protocol errors and worse outcomes. This exploratory analysis of dosimetric indices suggests that strict quality checks matter. While this trial was small, the link between errors and survival is clear. Patients need consistent care to get the best chance at long-term survival.

What this means for you:

Major treatment errors linked to shorter survival in head and neck cancer patients.

Study Details

Study typeRct

Sample sizen = 19

EvidenceLevel 2

Follow-up55.3 mo

PublishedMay 2026

PMID40714135

View Original Abstract ↓

PURPOSE: The OMET GORTEC 2014-04 trial showed prolonged survival with multisite Stereotactic Ablative Body Radiation therapy (SABR) in patients with oligometastatic head and neck cancer. However, deviations from radiation therapy protocol can be a confounding factor in clinical trials. The impact of SABR quality assurance by individual case review (ICR) of protocol deviations and quality metrics on survival and local control at SABR-treated oligometastases was assessed. METHODS AND MATERIALS: The SABR planning and delivery protocol was standardized based on the oligometastasis number/size/nearby critical structures (organs at risk [OARs]) across SABR techniques. ICR assessed oligometastatic topological complexity, indication, delineation (targets, OARs), image guidance, prescription, target coverage, and OAR doses. An exploratory analysis of quantitative dosimetric indices was also performed. RESULTS: Among 69 patients (98 metastases, unique 58.0%, lung-only 82.6%), there was no imbalance of deviations between the trial arms. Median follow-up was 55.3 months. Median overall survival was 61.7 months (IQR, 41.1-Not reached) in patients (N = 19) without deviation, 50.9 months (IQR, 32.1-Not reached) in patients (N = 36) with at least a minor deviation, and 20.9 months (IQR, 12.1-81.7) in those (N = 12) with at least a major deviation. Among patients with a major deviation, the conformity number (P < .001) and modified gradient index (P = .01) deviated more from their optimal values. CONCLUSIONS: Deviations from protocol by ICR were evenly distributed between arms. Major deviations were mostly related to the cumulative size of the oligometastases and OAR proximity and were associated with poorer survival in this SABR trial.

SABR Protocol Deviations Linked to Poorer Survival in Oligometastatic Head and Neck CancerMajor protocol deviations cut survival time for head and neck cancer patients

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