Voorbehandeling met bestraling en chemotherapie gevolgd door operatie versus alleen operatie voor operatief verwijderbare of mogelijk verwijderbare alvleesklierkanker. Een gerandomiseerd fase III onderzoek.
- Conditions
- resectable pancreatic carcinoma or borderline resectable pancreatic carcinomaresectabel of borderline resectabel pancreascarcinoom.
- Registration Number
- NL-OMON22251
- Lead Sponsor
- Academic Medical CenterDepartment of radiation oncologyMeibergdreef 91105 AZ AmsterdamThe NetherlandsPhone: +31 20 5665591E-mail: g.vantienhoven@amc.uva.nl
- Brief Summary
Van Tienhoven G, Gouma, DJ, Richel DJ. Neoadjuvant chemoradiotherapy has a potential role in pancreatic carcinoma Therapeutic Advances in Medical Oncology, 2011;3:27-33
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 244
Inclusion Criteria
1. Histologically or cytologically confirmed adenocarcinoma of the pancreas;
2. Primarily resectable tumours or Borderline resectable tumours (see table 1, p7 and hereunder) (exception, T1 centrally located tumours with no vascular involvement at all);
Exclusion Criteria
1. T1 resectable tumours, centrally located with no connection to the SMA, Celiac axis, CHA or SMV/PV;
2. Clearly locally advanced, irresectable, tumours (see table 1, p7 and hereabove);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival.
- Secondary Outcome Measures
Name Time Method To compare between the study arms:<br /><br>1. The resection rate;<br /><br>2. The microscopically complete (R0) resection rate;<br /><br>3. The disease free survival;<br /><br>4. The time to locoregional failure;<br /><br>5. The time to distant metastases;<br /><br>6. The postoperative complications and morbidity.<br><br /><br /><br>To assess in the experimental arm:<br /><br>1. The radiological response rates after preoperative radiochemotherapy (RECIST criteria);<br /><br>2. The pathological response rates after preoperative radiochemotherapy;<br /><br>3. The toxicity of preoperative radiochemotherapy according to Common Terminology Criteria for Adverse Events 4 (CTC-AE 4).