PANcreatic Cancer lOcalized disease in frail or elderly patients unfit for both chemotherapy and surgery treated with Stereotactic Ablative Radiotherapy (PANCOSAR): a multicenter randomized controlled trial

Phase 2

Recruiting

Conditions: pancreascarcinoom
pancreatic cancer
10017991

Registration Number: NL-OMON52822

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 98

Inclusion Criteria

• Pathology proven localised (non-metastasized) PC
• Patients unfit for both surgery and systemic chemotherapy (i.e. KPS 50-70;
WHO 2 or favourable WHO3) or patients who refuse surgery or chemotherapy.
In case of prior treatment with chemotherapy: A maximum of two cycles of
chemotherapy is aloud for inclusion. The interval between the last cycle of
chemotherapy and the first fraction of radiation therapy should be at least six
weeks. Additionally, in the case patient suffered from side effects of the
chemotherapy these have to score equal or below 1 (CTCAE v.5.0) in before the
first fraction of radiation therapy is delivered.
• Written informed consent

Exclusion Criteria

• Age <18 years
• Administration of more than two cycles of chemotherapy
• Distant metastasis
• Imminent bowel obstruction
• Active bleeding
• Uncontrolled infection
• Contra-indications for MRI (only for VUmc and UMCU)
- pacemakers or implanted defibrillators, deep brain stimulators, cochlear
implants. Patients who have a metallic foreign body in their eye, or who have
an aneurysm clip in their brain, cannot have an MRI scan since the magnetic
field may dislodge the metal
- Patients with severe claustrophobia not able to tolerate an MRI scan
- Patients with a non-MR-compatible (hip/knee/jaw) prosthesis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is to compare survival at six months in both study arms,<br /><br>measured from the time of randomization.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quality of life (QoL) assessment using the European Organization for Research<br /><br>and Treatment of Cancer (EORTC)<br /><br>quality-of-life score questionnaires (QLQ-C30, version 3.0 and EORTC-PAN26)<br /><br>assessed at baseline, 3-6-12 months<br /><br><br /><br>• Ca19.9: assessed at baseline, 3 and 6 months<br /><br>• Toxicity will be scored using CTCAE criteria version 5.0: assessed at<br /><br>baseline, day of last fraction, at 3 and 6 weeks (telephone consultation by<br /><br>Radiation Oncologist), 3-6-12 months<br /><br>• NRS pain score: assessed at baseline, 3-6-12 months<br /><br>• WHO performance score: assessed at baseline, 3-6-12 months<br /><br>Imaging after 3-6- and 12 months after treatment</p><br>