PAREO study
Recruiting
- Conditions
- Oesophagus carcinoma, cancer, paclitaxel, intra-tumoral
- Registration Number
- NL-OMON20604
- Lead Sponsor
- Erasmus University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
Age ¡Ý 18 years
- Oesophagus carcinoma
Exclusion Criteria
- Pregnant or lactating patients
- Previously treatment with radiotherapy on the oesophagus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a 25% reduction of the intra-tumoral concentrations of paclitaxel in cycle six compared to cycle one in oesophageal cancer patients.
- Secondary Outcome Measures
Name Time Method 1) To correlate the intra-tumoral concentrations of paclitaxel with pharmacokinetic paclitaxel parameters in plasma (i.e. AUC, CL, Cmax and tmax) per cycle. 2) To compare the concentrations of paclitaxel in tumor tissue compared to normal appearing mucosa. 3) To evaluate and to correlate toxicity with intra-tumoral paclitaxel concentrations. 4) To correlate tumor response (by RECIST) with intra-tumoral paclitaxel concentrations.