Evaluation of the intraoperative radiotherapy (IORT) in pancreatic adenocarcinoma. IOPANCA (IOrt in PANcreatic Cancer)

Not Applicable

Recruiting

Conditions: C25
Malignant neoplasm of pancreas

Registration Number: DRKS00023475

Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

1. Before registration, patient's written informed consent has been obtained
2. Age = 18 years, male and female patients
3. Legal capacity, patient is able to understand the nature, significance, and consequences of the study
4. Surgical and medical operability
5. WHO performance status = 2

Exclusion Criteria

1. Prior radiotherapy to the region(s) to be treated
2. Chemotherapy and/or targeted treatment within 2 weeks before the start of SBRT
3. Presence of infiltration of OARs such as tracheal, oesophageal infiltration or infiltration of small/large bowel or stomach
4. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The documentation of the delivered dose during IORT

Secondary Outcome Measures

Name	Time	Method
Definition of a QA procedure, which should also be applied in a multi-centre study. Acute and late toxicity (=90 days after RT is acute; late >90 days) measured as NCI-CTCAE v4.0 for adverse event reporting. Overall Survival Recurrence-free survival Patterns of local and distant recurrence Postoperative complications.