ATTENUATION – A multicenter randomized phase II study of the efficacy and safety de-escalation versus standard adjuvant chemotherapy in patients with low risk localized gastroesophageal adenocarcinoma (study PRODIGE/FRENCH 39)

assessed on a min. of 15 lymph nodes and, Completed both pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen (FLOT 4 cycles) and microscopically complete (R0) resection prior to randomization, defined by the following criteria: - Absence of lymph node involvement (ypN0), - Either ypT0-2 ( all TRG grade) or ypT3 (with TRG 1a-b according to Becker classification or TRG1-2 according to Mandard’s classification), esophageal or gastroesophageal junction adenocarcinoma, Low risk of disease recurrence, non-metastatic (M0) gastric

The 3-year Overall Survival (OS) rate, described as the proportion of patients still alive 3 years after the date of randomization

• Overall survival (OS), • Disease-Free Survival (DFS), • Pattern and rate of relapse, • Tolerability profile, • Health-related quality of life and nutritional status, and correlation of these parameters with survival outcomes, A cost-effectiveness analysis of a de-escalation strategy compared to the standard postoperative chemotherapy, A Human and Social Sciences sub-study will be conducted in both study arms to assess if emotional competences will be predictive of HRQoL (Global Health Status dimension of the QLQ-C30) and/or supportive care needs mediated by anxio/depressive symptoms

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