Fluorouracil for Gastroesophageal junction adenocarcinoma (adenocarcinoma of the gastroesophageal junction)

Inclusion criteria

• {"criterion_text":"- 1.\tHistologically proven, locally advanced and potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert I- III) that is: cT3-4, any N, or cT2 N+ M0 according to AJCC 8th edition\n- 10.\tWritten informed consent obtained before randomization\n- 11.\tNegative pregnancy test for women of childbearing potential within 7 days of commencing study treatment. Males and females of reproductive potential must agree to practice highly effective contraceptive measures*** during the study and for 6 months after the end of study treatment. Male patients must also agree to refrain from father a child during treatment and up to 6 months afterwards and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.\n- 2.\tPatients* must be candidates for potential curative resection as determined by the treating surgeon.\n- 3.\tECOG performance status 0-1\n- 4.\tAge 18 years or above\n- 5.\tAdequate hematologic function with absolute neutrophil count (ANC) ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l and hemoglobin ≥ 9.0 mg/dl\n- 6.\tINR <1.5 and aPTT<1.5 x upper limit of normal (ULN) within 7 days prior to randomization\n- 7.\tAdequate liver function as measured by serum transaminases (ASAT, ALAT) ≤ 2.5 x ULN and total bilirubin ≤ 1.5 x ULN\n- 8.\tAdequate renal function with serum creatinine ≤ 1.5 x ULN\n- 9.\tQTc interval (Bazett**) ≤ 440 ms"}

Exclusion criteria

• {"criterion_text":"- 1.\tEvidence of metastatic disease (exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI [if osseous lesions are suspected due to clinical signs])\n- 10.\tClinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV\n- 11.\tClinically significant valvular defect\n- 12.\tOther severe internal disease or acute infection\n- 13.\tPeripheral polyneuropathy > NCI Grade II according to CTCAE version 4.03\n- 14.\tChronic inflammatory bowel disease\n- 2.\tPast or current history (within the last 5 years prior to treatment start) of other malignancies. Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible\n- 3.\tEvidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 4.03 (see appendix)\n- 4.\tPatients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled\n- 5.\tPregnant or lactating females\n- 6.\tPatients medically unfit for chemotherapy and radiotherapy\n- 7.\tPatients receiving any immunotherapy, cytotoxic chemotherapy or radiotherapy other than defined by the protocol. The participation in another clinical trial with the use of investigational agents, chemotherapy or radiotherapy during the trial is not permitted\n- 8.\tKnown hypersensitivity against 5-FU, folinic acid, oxaliplatin or docetaxel\n- 9.\tOther known contraindications against 5-FU, folinic acid, oxaliplatin, or docetaxel"}

Primary endpoints

• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":"Primary objective: to investigate whether the addition of preoperative radiochemotherapy is superior to perioperative chemotherapy alone by improving progression-free survival in patients undergoing oncologically adequate surgery (D2 resection and appropriate mediastinal lymphadenectomy)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival, including survival rates after 1, 3 and 5 years","definition_or_measurement_approach":"Overall survival measured as time from randomization to death; survival rates assessed at 1, 3 and 5 years (as stated)."}
• {"endpoint_text":"- R0 resection rate","definition_or_measurement_approach":"Proportion of patients with R0 (complete) resection as assessed at surgery."}
• {"endpoint_text":"- Number of harvested lymph nodes","definition_or_measurement_approach":"Count of lymph nodes removed and examined at surgery."}
• {"endpoint_text":"- Site of tumor relapse","definition_or_measurement_approach":"Anatomic location(s) of documented tumor recurrence."}
• {"endpoint_text":"- Perioperative morbidity and mortality rate","definition_or_measurement_approach":"Rates of perioperative complications and perioperative deaths."}
• {"endpoint_text":"- Safety and toxicity as assessed by NCI CTC criteria","definition_or_measurement_approach":"Adverse events graded according to NCI Common Toxicity Criteria (CTC)."}
• {"endpoint_text":"- Quality of life by using the EORTC QLQ-C30 and the esophagogastric module OG25","definition_or_measurement_approach":"Patient-reported quality of life assessed using the EORTC QLQ-C30 and OG25 instruments."}

Germany

Earliest CTIS Part Ii Submission Date

19-09-2024

Latest Decision Or Authorization Date

12-11-2024

Processing Time Days

54

Number Of Participants

342

Primary sponsor

Full Name

Universitat Heidelberg

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"Stiftung Deutsche Krebshilfe","duties_or_roles":"Source of monetary support / funder","organisation_type":""}