Phase II Study of Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma
An open-label, single-centre, non-randomized, Phase II trial in patients with esophageal adenocarcinoma. This study aims to show that delivering hypofractionated neoadjuvant concurrent chemoradiotherapy is is equally effective as conventionally fractionated neoadjuvant concurrent chemoradiotherapy.
• Biopsy-proven invasive adenocarcinoma of the esophagus or GEJ (Siewart type I-II)
• Surgically resectable clinical stage T1N1-3 or T2-3N0-3 and no clinical evidence of metastatic spread are eligible (M0).
• Maximum length (based on best information available, with EGD preferred) and width of the tumor as seen on CT not exceeding 8 cm and 5 cm respectively.
• ECOG performance status ≤ 2
• Patient able to begin radiation treatment within 30 calendar days of signing the informed consent form.
• Age ≥ 18 and ≤ 80.
• Adequate hematological, renal, hepatic and pulmonary function as defined by:
‣ Hemoglobin \> 100 g/L
⁃ Platelet count \> 100x109/L
⁃ Absolute neutrophil count \> 1.5x109/L
⁃ Total bilirubin ≤ 1.5x the upper limit of institutional normal
⁃ Creatinine ≤ 120 µmol/L
⁃ FEV1 ≥ 1.5 L
• Patients capable of childbearing are using adequate contraception.
• Written and informed consent of patient.