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

February 27, 2020 updated by: Lund University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Lund University Hospital, Department of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).
Radiotherapy (5 x 4 Gy) will be given. After completion of radiotherapy, 4 cycles of chemotherapy will be administered, cycle length 14 days. Each patient will receive oxaliplatin as infusion at a dose of 85 mg/m2, followed by a bolus injection of fluorouracil at a dose of 400 mg/m2, and a long time infusion (44 hours) of fluorouracil at a dose of 2 400 mg/m2.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of dysphagia.
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Time Frame
Endoscopic response of the primary tumor.
Time Frame: Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.
Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.

Other Outcome Measures

Outcome Measure
Time Frame
Metabolic response
Time Frame: Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy.
Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Investigators

  • Principal Investigator: David Borg, MD, Lund University Hospital, Department of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBG01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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