ADJUPANC protocol: a phase III study of adjuvant chemotherapy versus chemoradiotherapy for pancreatic cancer.

Abstract

Adjuvant chemotherapy has shown favorable outcomes for pancreatic cancer. However, the role of adding radiotherapy to chemotherapy remained conflicting and lacked robust evidence to show improved survival compared with chemotherapy alone. Previous meta-analyses based on retrospective studies and database demonstrated that patients with lymph nodal metastases, positive microscopic margins or positive margins, or lymphovascular invasion may obtain survival benefits from adjuvant chemoradiotherapy. This multicenter, randomized, open-label, phase III trial aim to compare the efficacy of adjuvant chemoradiotherapy and chemotherapy for pancreatic cancer harboring pathological features predictive of a high risk of recurrence. Seven hundred and seventy patients will be recruited and randomized in a 1:1 ratio into the adjuvant chemoradiotherapy and chemotherapy group. Patients will receive gemcitabine and capecitabine in adjuvant chemotherapy group. In the adjuvant chemoradiotherapy group, patients will first receive the same regimen as that of the adjuvant chemotherapy group and then concurrent chemoradiotherapy (the prescription dose of 50-54 Gy in 25-27 fractions and capecitabine). ADJUPANC aims to investigate whether adjuvant chemoradiotherapy contributes to favorable outcomes for patients with pancreatic cancer harboring lymph nodal metastases, positive microscopic margins or positive margins, or lymphovascular invasion compared with adjuvant chemotherapy. This may provide evidence for individualized treatment for pancreatic cancer.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06427447.