DOCETAXEL for Non-metastatic gastric adenocarcinoma|Non-metastatic esophageal adenocarcinoma|Non-metastatic gastroesophageal junction adenocarcinoma

Inclusion criteria

• {"criterion_text":"-I1.\tAge ≥ 18 years"}
• {"criterion_text":"-I2.\tHistologically proven non-metastatic (M0) gastric, esophageal or gastroesophageal junction adenocarcinoma"}
• {"criterion_text":"-I3.\tSubjects must have completed both pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen (FLOT 4 cycles) and microscopically complete (R0) resection prior to randomization. Note for surgery: total or distal gastrectomy with D2 lymphadenectomy according to ESMO guidelines should have been completed for gastric and junctional Siewert type III cancers. Ivor Lewis oesophagectomy with two field lymphadenectomy should have been performed for junctional Siewert type I cancers and lower esophageal adenocarcinomas. For Siewert type II cancers either total gastrectomy with D2-lymphadenectomy or oesophagectomy with two field lymphadenectomy should have been completed. Open, minimal invasive or hybrid surgical approaches are acceptable as long as the requirements above are fulfilled. In frail patients with Siewert I or II, transhiatal oesophagectomy with lymphadenectomy in the lower mediastinum without transthoracic access is acceptable. Regardless of the type of surgery a minimum of 16 (gastric cancer) or 7 lymph nodes (in case of esophageal carcinoma) should have been resected and examined (ref TNM 8 eme edition"}
• {"criterion_text":"-I4.\tLow risk of disease recurrence, defined by the following criteria: -\tAbsence of lymph node involvement (ypN0), assessed on a min. of 16 or 7 lymph nodes according to the localization and, -\tEither ypT0-2 (all TRG grade) or ypT3 (with TRG 1a-b according to Becker classification or TRG1-2 according to Mandard’s classification),"}
• {"criterion_text":"-I5.\tECOG Performance Status 0-1"}
• {"criterion_text":"-I6.\tPatients fit to receive post-operative chemotherapy"}
• {"criterion_text":"-I7.\tInterval between the date of surgery and the date of randomization no longer than 10 weeks"}
• {"criterion_text":"-I8.\tAdequate organs function (ranges defined in the clinical trial protocol)"}
• {"criterion_text":"-I9.\tNo contraindication to study assessments,"}
• {"criterion_text":"-I10.\tSigned and dated informed consent for prior to any study-specific procedure"}
• {"criterion_text":"-I11.\tWomen of childbearing potential accepting to use highly effective contraceptive measures or abstain from heterosexual activity, for the course of the study and at least an- 9 months after the end of the treatment with oxaliplatin - 6 months after the end of the treatment with fluorouracil - 2 months after the end of the treatment with docetaxel and men must use contraception during treatment and at least - 6 months after the end of the treatment with oxaliplatin, - 3 months after the end of the treatment with fluorouracil - 4 months after the end of the treatment with docetaxel."}
• {"criterion_text":"-I12.\tPatient must be covered by a medical insurance or equivalent"}

Exclusion criteria

• {"criterion_text":"-E1.\tOesophageal squamous cell carcinomas"}
• {"criterion_text":"-E2.\tTumor with Deficient MisMatch Repair (MMR) and/or Microsatellite Instability status"}
• {"criterion_text":"-E3.\tDihydro Pyrimidine Dehydrogenase (DPD) deficiency, NB: if not previously done, the following blood chemistry level must be perform at screening, : blood uracil level - uracilemia dosing result is mandatory prior the inclusion"}
• {"criterion_text":"-E4.\tPersistent toxicities related to prior treatment of grade>1,"}
• {"criterion_text":"-E5.\tQTcF longer than 450 msec for men and longer than 470 msec for women,"}
• {"criterion_text":"-E6.\tHypokalemia OR Hypomagnesemia OR Hypocalcemia Grade>1"}
• {"criterion_text":"-E7.\tContraindication to postoperative treatment (FLOT): •\tKnown history of hypersensitivity to fluorouracil, oxaliplatin, docetaxel or calcium folinate to any of their excipients, according to the SmPCs of these products OR •\tPeripheral sensory neuropathy with functional impairment prior to first treatment according the SmPC of oxaliplatin OR •\tClinically significant active heart disease or myocardial infarction within 6 months OR •\t •\tRecent or concomitant treatment with brivudine or recent treatment with live vaccines (minimal wash out period before randomisation: 4 weeks)"}
• {"criterion_text":"-E8.\tAny concurrent chemotherapy, Investigational product for cancer treatment."}
• {"criterion_text":"-E9.\tConcurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study"}
• {"criterion_text":"-E10.\tSuspicion of serious infection"}
• {"criterion_text":"-E11.\tPregnant or breastfeeding woman"}
• {"criterion_text":"-E12.\tPatient under tutorship or curatorship of deprived of liberty."}

Primary endpoints

• {"endpoint_text":"-The 3-year Overall Survival (OS) rate, described as the proportion of patients still alive 3 years after the date of randomization","definition_or_measurement_approach":"Described as the proportion of patients still alive 3 years after the date of randomization"}

Secondary endpoints

• {"endpoint_text":"-•\tOverall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"-•\tDisease-Free Survival (DFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"-•\tPattern and rate of relapse","definition_or_measurement_approach":""}
• {"endpoint_text":"-•\tTolerability profile","definition_or_measurement_approach":""}
• {"endpoint_text":"-•\tHealth-related quality of life and nutritional status, and correlation of these parameters with survival outcomes","definition_or_measurement_approach":""}
• {"endpoint_text":"-A cost-effectiveness analysis of a de-escalation strategy compared to the standard postoperative chemotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"-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","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

12-06-2024

Latest Decision Or Authorization Date

23-07-2024

Processing Time Days

41

Number Of Sites

21

Number Of Participants

120

Primary sponsor

Full Name

Centre Leon Berard

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France