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Clinical Trials/EUCTR2014-002362-74-SE
EUCTR2014-002362-74-SE
Active, not recruiting
Not Applicable

Palliative short-course hypofractionated radiotherapy followed by chemotherapy in adenocarcinoma of the esophagus or esophogastric junction trial - a phase II clinical trial protocol. - PALAESTRA

Skåne University Hospital, Department of Oncology0 sitesJune 27, 2014
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Skåne University Hospital, Department of Oncology
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 27, 2014
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Skåne University Hospital, Department of Oncology

Eligibility Criteria

Inclusion Criteria

  • •\- Patients with histologically proven adenocarcinoma of the esophagus or esophago\-gastric junction (Siewert
  • •I\-III) not eligable for surgery or chemoradiation with curative intent
  • •\- TNM: any T, N and M
  • •\- Age: 18 years or older
  • •\- WHO performance status \= 2
  • •\- Life expectancy \> 3 months
  • •\- Dysphagia score \> 0 (see section 9\.1\)
  • •\- Adequate laboratory findings:
  • •hematological: hemoglobin \> 90 g/L (may be transfused to maintain or exceed this level), absolute neutrophil count (ANC) \= 1,0 x 109/L, platelets \=
  • •hepatic: bilirubin \= 1\.5 x ULN, ALAT \= 5 x ULN

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 version 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

Outcomes

Primary Outcomes

Not specified

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