Patients with adenocarcinoma of the esophagus or esophagogastric junction. MedDRA version: 17.0 Level: LLT Classification code 10056092 Term: Adenocarcinoma of oesophagus System Organ Class: 100000004864
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentra
Sponsors
Skåne University Hospital, Department of Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histologically proven adenocarcinoma of the esophagus or esophago-gastric junction (Siewert I-III) not eligable for surgery or chemoradiation with curative intent - TNM: any T, N and M - Age: 18 years or older - WHO performance status = 2 - Life expectancy > 3 months - Dysphagia score > 0 (see section 9.1) - Adequate laboratory findings: hematological: hemoglobin > 90 g/L (may be transfused to maintain or exceed this level), absolute neutrophil count (ANC) = 1,0 x 109/L, platelets = 75 x 109/L hepatic: bilirubin = 1.5 x ULN, ALAT = 5 x ULN renal: creatinine = 1.5 x ULN - Fertile men and women must use effective means of contraception - Signed written informed consent - The patient must be able to comply with the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: - Prior treatment with self-expanding metal stent (SEMS), radiotherapy or chemotherapy for the present disease - Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure - Severe pulmonary disease e.g. pulmonary fibrosis. - Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.0) - Known hypersensitivity to any contents of the study drugs - Pregnancy (positive pregnancy test) and/or breast feeding - Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the rate of improvement in dysphagia after palliative short-course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy (FOLFOX x 4) in patients with adenocarcinoma of the esophagus or esophago-gastric junction not eligible for surgery or chemoradiation with curative intent ;Secondary Objective: - To determine the endoscopic response of the primary tumor - To determine the metabolic response (using FDG-PET) in the primary tumor and metastases respectively - To determine the response of the metastatic disease on CT-scans according to RECIST-criteria version 1.1 - To determine OS -To determine treatment related toxicity;Primary end point(s): Rate of improvement in dysphagia after short-course hypofractionated radiotherapy followed by 4 cycles of chemotherapy (FOLFOX x 4);Timepoint(s) of evaluation of this end point: After end of radiotherapy (before start of chemotherapy), before each cycle of chemotherapy (every second week), 4 weeks after end of treatment, and then once monthly until further local intervention or patients death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Endoscopic response Metabolic response Overall survival Toxixity;Timepoint(s) of evaluation of this end point: Endoscopic response is evaluated 4 weeks after end of treatment. Metabolic response is evaluated 1-3 weeks after end of treatment. Overall survival is evaluated until patients death. Toxicity is evaluated during treatment period, and for 4 weeks after. | — |
Countries
Sweden
Contacts
Public ContactDepartment of Oncology
Skåne University Hospital
Outcome results
None listed