A radical Chemoradiation schedule with hypofractionated radiotherapy plus capecitabine for esophageal cancer patients that are unfit for the standard chemoradiation; a phase II study
- Conditions
- non-metastasized esophageal cancer
- Registration Number
- NL-OMON25277
- Lead Sponsor
- amsterdamumc
- Brief Summary
75846.029.20 Eudract2020-006164-85
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 28
Age of 18 years or older
-WHO performance score 0-3
-Biopsy proven carcinoma of the esophagus
-cT1-T4aN0-3M0, including patients with M1 disease based on pathologic nodes at supraclavicular or truncus coeliacus level
-The multidisciplinary team rejects surgical treatment
-The radiation oncologist and medical oncologist consider patient not eligible for the standard chemoradiation, with at least one of the following characteristics: WHO performance 3, age of > 80 year, metabolic disorders excluding Carboplatin or Paclitaxel, mainly wheelchair bounded, evidence of interstitial lung disease or active, non-infectious pneumonitis, or a Charlson index of 3 or more.
-Previous irradiation overlapping with the intended fields
-Stent in situ
-Serum DPD deficiency
-Prior intravenous chemotherapy for esophageal cancer
-An active infection requiring systemic therapy
-Has known psychiatric disorders or substance abuse disorders that would interfere with cooperation in the trial
-Inability, or serious suspicion of inability to administer the prescribed doses of capecitabine
-Is pregnant or breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method compliance to treatment
- Secondary Outcome Measures
Name Time Method locoregional control