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

Lund University Hospital

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma of the Esophagus or Esophagogastric Junction

Treatments: Radiation: Radiation therapy; Drug: Oxaliplatin and fluorouracil.

Study type: Interventional

Funder types: Other

Identifiers

NCT02241499

DBG01

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).

Experimental group

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.

Treatment:

Radiation: Radiation therapy

Drug: Oxaliplatin and fluorouracil.