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Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.

NCT02241499 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-02-28

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma of the Esophagus or Esophagogastric Junction

Interventions

RADIATION

Radiation therapy

Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days.

DRUG

Oxaliplatin 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 & Collaborators

  • Lund University Hospital

    lead OTHER

Principal Investigators

  • David Borg, MD · Lund University Hospital, Department of Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02241499 on ClinicalTrials.gov