Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
Conditions
Adenocarcinoma of the Esophagus or Esophagogastric Junction.
Conditions: official terms
Adenocarcinoma - Esophageal Neoplasms
Conditions: Keywords
Digestive System Diseases, Esophageal cancer, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Endoscopic response, Fluorouracil, Metabolic response, Oxaliplatin, Radiotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiation therapy Type: Radiation
Name: Oxaliplatin and fluorouracil. Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Lund University Hospital, Department of Oncology
Lund, Sweden
Status: Recruiting
Contact: David Borg, MD - +46 46 17 75 20 - david.borg@skane.se
Start Date
October 2014
Completion Date
October 2017
Sponsors
Lund University Hospital
Source
Lund University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page