Gemcitabine en radiotherapie in combinatie met panitumumab bij patiënten met niet uitgezaaide, inoperabele alvleesklierkanker.
Recruiting
- Conditions
- Pancreatic cancerPancreas cancerAlvleesklierkankerPancreaskanker
- Registration Number
- NL-OMON25995
- Lead Sponsor
- Prof. dr. H.M.W. Verheul, M.D., Ph.D.Head Department of Medical OncologyVU University Medical CenterDe Boelelaan 11171081 HV AmsterdamPhone: +31-20-4444321/300Fax: + 31-20-4444079Email: h.verheul@vumc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 63
Inclusion Criteria
1. Histological or cytological confirmed pancreatic cancer;
2. Not eligible for curative resection;
Exclusion Criteria
1. Participation in another therapeutic clinical study within 30 days of enrollment or during this clinical study;
2. No adequate radiation therapy possible: based on the opinion of the radiation oncologist when radiation therapy cannot be performed because radiation field is too large (PTV volume too large or OAR too high);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I part:<br /><br>To determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.<br><br /><br /><br>Phase II part: <br /><br>1. To investigate the proportion of patients with inoperable locally advanced pancreatic cancer receiving chemoradiation with gemcitabine plus panitumumab as first line treatment, that is progression-free at 7 months;<br /><br>2. To evaluate the safety and tolerability for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.
- Secondary Outcome Measures
Name Time Method 1. To assess early signs of clinical activity of the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer;<br /><br>2. To assess the clinical response rate of the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer;<br /><br>3. To assess time-to-progression (TTP) and overall survival amongst patients with inoperable locally advanced pancreatic cancer receiving chemoradiation with gemcitabine plus panitumumab as first line treatment.