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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. (PALAESTRA)

Primary Purpose

Adenocarcinoma of the Esophagus or Esophagogastric Junction

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Radiation therapy
Oxaliplatin and fluorouracil.
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Esophagus or Esophagogastric Junction focused on measuring Digestive System Diseases, Esophageal cancer, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Endoscopic response, Fluorouracil, Metabolic response, Oxaliplatin, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lund University Hospital, Department of Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement of dysphagia.
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.

Secondary Outcome Measures

Endoscopic response of the primary tumor.

Full Information

First Posted
September 8, 2014
Last Updated
February 27, 2020
Sponsor
Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02241499
Brief Title
Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
Acronym
PALAESTRA
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin and fluorouracil.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of dysphagia.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Endoscopic response of the primary tumor.
Time Frame
Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.
Other Pre-specified Outcome Measures:
Title
Metabolic response
Time Frame
Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Borg, MD
Organizational Affiliation
Lund University Hospital, Department of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University Hospital, Department of Oncology
City
Lund
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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