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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02241499
• Date of registration: 08/09/2014
• Prospective Registration: Yes
• Primary sponsor: Lund University Hospital
• Public title: Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol. PALAESTRA
• Scientific title: Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
• Date of first enrolment: October 2014
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02241499
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Sweden

Contacts

• Name: David Borg, MD
• Affiliation: Lund University Hospital, Department of Oncology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Adenocarcinoma of the Esophagus or Esophagogastric Junction

Intervention(s)

Drug: Oxaliplatin and fluorouracil.

Radiation: Radiation therapy

Primary Outcome(s)

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.]

Secondary Outcome(s)

Endoscopic response of the primary tumor. [Time Frame: Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.]

Secondary ID(s)

DBG01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors