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

Phase 2

Completed

• Conditions: Adenocarcinoma of the Esophagus or Esophagogastric Junction
• Interventions: Radiation: Radiation therapy; Drug: Oxaliplatin and fluorouracil.

• Registration Number: NCT02241499
• Lead Sponsor: Lund University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Study Start: 2014-10
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).	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.
Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).	Radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
Improvement of dysphagia.	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 Outcome Measures

Name	Time	Method
Endoscopic response of the primary tumor.	Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.

Trial Locations

Locations (1)

Lund University Hospital, Department of Oncology; 🇸🇪 Lund, Sweden