Details

Autor(en) / Beteiligte

• Casadei, Riccardo
• Di Marco, Mariacristina
• Ricci, Claudio
• Santini, Donatella
• Serra, Carla
• Calculli, Lucia
• D’Ambra, Marielda
• Guido, Alessandra
• Morselli-Labate, Antonio Maria
• Minni, Francesco

Titel

Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets

Ist Teil von

• Journal of gastrointestinal surgery, 2015-10, Vol.19 (10), p.1802-1812

Ort / Verlag

New York: Springer US

Erscheinungsjahr

2015

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Objective The objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer. Methods A single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A (surgery alone) and arm B (neoadjuvant chemoradiation and surgery). The primary endpoint was R0 resection; the secondary endpoints were toxicity; number of patients who completed the neoadjuvant therapy; radiological and pathological response after chemoradiation; and pTNM stage, postoperative morbidity, mortality, and overall and disease-free survival. A sample size of 32 patients was required for each group. Results The study was terminated early, and 38 patients were randomized: 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups (intention-to-treat, OR = 1.91, P  = 0.489). Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases (77.8 %) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases, respectively. Conclusions Neoadjuvant chemoradiation was feasible, safe, and efficacious, although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients. Additional multicenter RCTs are needed in the future.