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

NCT ID: NCT02241499

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-05-31

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.

Conditions

Adenocarcinoma of the Esophagus or Esophagogastric Junction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Radiation therapy

Intervention Type: 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.

Intervention Type: 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.

Interventions

Radiation therapy

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

Intervention Type: RADIATION

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Borg, MD

Role: PRINCIPAL_INVESTIGATOR

Lund University Hospital, Department of Oncology

Locations

Lund University Hospital, Department of Oncology

Lund, , Sweden

Countries

Sweden

Other Identifiers

DBG01

Identifier Type: -

Identifier Source: org_study_id