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NCT Number: NCT02241499

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

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.

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Key information

Conditions

Adenocarcinoma of the Esophagus or Esophagogastric Junction Adenocarcinoma Of Esophagus Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lund University Hospital, Department of Oncology

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

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

Oxaliplatin and fluorouracil.

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. 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 outcomes

  1. Metabolic response

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

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Acronym: PALAESTRA

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2014
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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