Ablative ultra-hypofractionated radiotherapy with surgical GI exclusion as a “functional spacer” for pancreatic cancer: a phase I safety and feasibility study
Mené sur 10 patients atteints d'un cancer du pancréas localement avancé, cet essai de phase I évalue la faisabilité et la sécurité d'une radiothérapie ultra-hypofractionnée d'ablation suivie immédiatement d’un pontage gastro-intestinal prophylactique
Objectives: The therapeutic window for radiotherapy in locally advanced pancreatic cancer (LAPC) is severely constrained by the anatomical proximity of the duodenum. We hypothesized that radiation-induced gastrointestinal (GI) injury is exacerbated by physiological digestion, and that surgically bypassing the irradiated duodenum would provide a biological “functional spacer.” We aimed to evaluate the safety and clinical feasibility of ablative ultra-hypofractionated radiotherapy (UHRT) followed directly by elective GI exclusion surgery.
Methods: In this prospective Phase I protocol, 10 patients with LAPC received ablative UHRT using Helical Tomotherapy at a prescribed dose of 40–60 Gy in 5 fractions. A prophylactic GI exclusion surgery (gastric truncation and GI bypass) was strictly scheduled within 7 days post-radiotherapy to place the high-dose irradiated duodenal segment into physiological quiescence. The primary endpoint was treatment safety assessed via CTCAE v4.02 and technical feasibility.
Results: All participants provided written informed consent and successfully completed the combined radiotherapeutic and surgical protocol. After a median follow-up of 12 months, no Grade 4–5 toxicities, bleeding, or gastrointestinal perforations were recorded. Only one patient (10%) experienced Grade 3 GI toxicity (abdominal pain). The Objective Response Rate (ORR) was 50%, with a 1-year overall survival rate of 60%. Furthermore, 70% of symptomatic patients achieved significant cancer-related pain relief.
Conclusions: Preliminary results suggest that the integration of ablative UHRT with an immediate prophylactic surgical GI bypass is a feasible and safe protocol. This “functional spacer” concept potentially mitigates the duodenal dose-limiting bottleneck, allowing the practical delivery of biologically ablative radiation doses in LAPC without catastrophic GI consequences. However, larger multi-center trials are warranted for further validation.
BMC Cancer , article en libre accès, 2026