Adenocarcinoma of the Esophagus or Esophagogastric Junction
Conditions
Keywords
Digestive System Diseases, Esophageal cancer, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Endoscopic response, Fluorouracil, Metabolic response, Oxaliplatin, Radiotherapy
Brief summary
In this trial, patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent will be included. Primary objective is to determine the rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an improvement.
Interventions
RADIATIONRadiation therapy
Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days.
DRUGOxaliplatin and fluorouracil.
Oxaliplatin at a dose of 85 mg/m2 and will be given on day 1, infusion (44 hours) of fluorouracil will be given for 4 cycles, cycle length 14 days.
Sponsors
Lund University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent * Any T, N and M * Age: 18 years or older * WHO performance status ≤ 2 * Life expectancy \> 3 months * Dysphagia score \> 0 * Adequate laboratory findings: hemoglobin \> 90 g/L, absolute neutrophil count * 1.0 10 9/L, platelets ≥ 75 x 10 9/L, bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN, creatinine ≤ 1.5 x ULN * Fertile men and women must use effective means of contraception * Signed written informed concent * The patient must be able to comply with the protocol
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 v. 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 | Description |
|---|---|---|
| Improvement of dysphagia. | The grade of dysphagia is evaluated before start of treatment, 1-4 weeks after end of radiotherapy, then until local intervention or death, average of 12 months. | The rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an approvement. |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic response of the primary tumor. | Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy. |
Other
| Measure | Time frame |
|---|---|
| Metabolic response | Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy. |
Countries
Sweden
Outcome results
None listed