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

NCT02241499 | Completed Phase 2

• 1 other identifier: DBG01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Keywords

Digestive System Diseases; Esophageal cancer; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Endoscopic response; Fluorouracil; Metabolic response; Oxaliplatin; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Endoscopic response of the primary tumor.

  Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.

Other Outcomes (1)

• Metabolic response

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

Study Arms (1)

Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).

EXPERIMENTAL

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.

Radiation: Radiation therapy; Drug: Oxaliplatin and fluorouracil.

Interventions

Radiation therapy RADIATION

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

Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).

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.

Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• /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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Lund University Hospital, Department of Oncology

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Digestive System Diseases; Esophageal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms

Interventions

Radiotherapy; Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Borg, MD

  Lund University Hospital, Department of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 16, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

SE (1)