Status:
COMPLETED
Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
Lead Sponsor:
Lund University Hospital
Conditions:
Adenocarcinoma of the Esophagus or Esophagogastric Junction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02241499
Start Date
October 1 2014
End Date
May 1 2019
Last Update
February 28 2020
Active Locations (1)
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1
Lund University Hospital, Department of Oncology
Lund, Sweden, 221 85