Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) MedDRA version: 20.1 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 5-Fluorouracil
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 5-Fluorouracil
Other descriptive name: FLUOROURACIL
Product Name: Calcium Folinate
Pharmaceutical Form: S
Sponsors
Ruprecht-Karls-Universität Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically 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 2. Patients* must be candidates for potential curative resection as determined by the treating surgeon. 3. ECOG performance status 0-1 4. Age 18 years or above 5. Adequate hematologic function with absolute neutrophil count (ANC) = 1.5 x 10^9/l, platelets = 100 x 10^9/l and hemoglobin = 9.0 mg/dl 6. INR =65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
Exclusion criteria: 1. Evidence 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]) 2. Past 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 3. Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 4.03 (see appendix) 4. Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled 5. Pregnant or lactating females 6. Patients medically unfit for chemotherapy and radiotherapy 7. Patients 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 8. Known hypersensitivity against 5-FU, folinic acid, oxaliplatin or docetaxel 9. Other known contraindications against 5-FU, folinic acid, oxaliplatin or docetaxel 10. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV 11. Clinically significant valvular defect 12. Other severe internal disease or acute infection 13. Peripheral polyneuropathy > NCI Grade II according to CTCAE version 4.03 14. Chronic inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if adding radiochemotherapy to neoadjuvant chemotherapy before undergoing oncologically adequate resection improves progression free survival of patients with resectable GEJ adenocarcinoma ;Secondary Objective: • To evaluate overall survival, including survival rates after 1, 3 and 5 years • To assess the R0 resection rate • To assess the number of lymph nodes harvested during surgery • To determine the site of tumor relapse • To assess the perioperative morbidity and mortality rate • To assess Safety and toxicity by NCI CTC criteria • To assess the quality of life (QoL) by using the EORTC QLQ-C30 and the esophagogastric module OG25;Primary end point(s): Progression-free survival (PFS) due to the addition of preoperative radiochemotherapy compared to perioperative chemotherapy alone in patients undergoing oncologically adequate surgery in the treatment of resectable GEJ adenocarcinoma;Timepoint(s) of evaluation of this end point: After surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival, including survival rates after 1, 3 and 5 years R0 resection rate Number of harvested lymph nodes Site of tumor relapse Perioperative morbidity and mortality rate Satefy and toxicity by NCI CTC criteria Quality of life (QoL) by using the EORTC QLQ-C30 and the esophagogastric module OG25;Timepoint(s) of evaluation of this end point: Overall survival, including survival rates: after 1, 3 and 5 years R0 resection rate: after surgery Number of harvested lymph nodes: after surgery Site of tumor relapse. Perioperative morbidity and mortality rate: after surgery Satefy and toxicity by NCI CTC criteria Quality of life (QoL) by using the EORTC QLQ-C30 and the esophagogastric module OG25 | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Ralf-Dieter Hofheinz
Universitätsmedizin Mannheim
Outcome results
None listed