Clinical trial NCT02241499: Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
Official title: Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Esophagus or Esophagogastric Junction
Keywords: Digestive System Diseases
Esophageal cancer
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Endoscopic response
Fluorouracil
Metabolic response
Oxaliplatin
Radiotherapy
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Improvement of dysphagia.
timeFrame: 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.
Secondary outcomes:
measure: Endoscopic response of the primary tumor.
timeFrame: Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.
Other outcomes:
measure: Metabolic response
timeFrame: Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy.
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital, Department of Oncology
Study officials:
affiliation: Lund University Hospital, Department of Oncology
name: David Borg, MD
role: PRINCIPAL_INVESTIGATOR
References: