SPAN-C was a single centre, single-arm, phase II clinical trial performed by the Pancreatic Group at RNSH which enrolled 30 patients with locally advanced, borderline resectable and/or metastatic pancreatic cancer. Following induction chemotherapy patients were treated with 35 to 45 Gy in 5 fractions of external beam radiotherapy. Fiducial marker (FM) placement was mandated. Primary endpoint was freedom from local failure at 12 months and secondary endpoints included survival, acute and late toxicity, surgical outcomes and palliation.
Results
Median FU was 35.2 months (QR 30.8-39.5). Twenty-six patients completed per protocol treatment (4 FM placement failures). Nine patients (34.6%) became resectable, 4 of whom had R0 resection and 2 had complete pathologic response. Survival data is pending. The maximum toxicity recorded was grade 3, with 3/26 patients (11.5%) reporting acute grade 3 toxicity. No patients reported late high grade toxicity. Nine patients (34.6%) had local recurrences, 6 required instrumentation and none had uncontrolled pain at death.
Conclusions
SBRT was safe and feasible with high rates of local control at 12 months and low rates of toxicity. A significant proportion of patients were converted to resectable status. Local palliation was excellent.