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

Conditions: Patients with adenocarcinoma of the esophagus or esophagogastric junction.
MedDRA version: 17.0Level: LLTClassification code 10056092Term: Adenocarcinoma of oesophagusSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-002362-74-SE

Lead Sponsor: Skåne University Hospital, Department of Oncology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 =
75 x 109/L
hepatic: bilirubin = 1.5 x ULN, ALAT = 5 x ULN
renal: creatinine = 1.5 x ULN
- Fertile men and women must use effective means of contraception
- Signed written informed consent
- The patient must be able to comply with the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

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