par Bouchart, Christelle ;Navez, Julie ;Manderlier, Martin ;Moretti, Luigi ;Van Laethem, Jean-Luc
Référence Revue médicale de Bruxelles, 44, 5, page (507-510)
Publication Publié, 2023-10-01
Article révisé par les pairs
Résumé : For patients with borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC), the use of neoadjuvant therapies before surgery is an emerging concept and the optimal therapeutic sequence to be employed for obtaining a chance of cure remains unknown. Based on the studies recently published by our team and which will be summarized in this article, we demonstrated that high-dose isotoxic stereotactic body radiation therapy (iHD-SBRT) can be safely integrated into a neoadjuvant chemotherapy regimen with promising benefits in terms of R0 resection (R0=complete resection), local control and survival. In this context, we designed and launched the phase II multicenter randomized controlled trial, STEREOPAC, whose objective is to evaluate the impact of the addition of iHD-SBRT to neoadjuvant chemotherapy in 256 patients with BR pancreatic cancer. After 4 cycles of mFOLFIRINOX (mFFX; or 6 doses of Gemcitabine/ nab-paclitaxel [Gem/Nab-P] in case of intolerance), non-progressive patients will be randomized to receive: 1/ 4 additional cycles of mFFX (or 6 doses of Gem/Nab-P) (arm A), or 2/ 2 cycles of mFFX (or 3 doses of Gem/Nab-P) + iHD-SBRT (35 to 55Gy in 5 fractions) + 2 cycles of mFFX (or 3 doses of Gem/Nab-P) (arm B). Then, curative surgery will be performed followed by adjuvant chemotherapy depending on the general condition of the patient. The co-primary endpoints of the trial are R0 resection and disease-free survival after the full treatment strategy. Therefore, the STEREOPAC trial will help define the best neoadjuvant strategy for patients with BR PDAC and aims to assess whether the integration of iHD-SBRT can improve the oncological results of these patients.

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