Dose-escalation with MR-guided stereotactic radiotherapy in isolated malignancies in the upper abdomen (RADIOPANC): a phase I dose finding trial

Recruiting

• Conditions: Pancreatic malignancies - Pancreatic tumors; 10014713

• Registration Number: NL-OMON52302
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Either patients with an unresectable, isolated malignancy (primary tumor or
oligometastasis) or inoperable patients with a resectable, isolated malignancy
(primary tumor or oligometastasis) in the upper abdominal region;
- Patients referred for SBRT by a multidisciplinary consultation of medical
specialists for local control or palliative care;
- Performance status WHO 0-2 with a minimal expected lifespan of >6 months;
- Written informed consent.

Exclusion Criteria

- Age <18 years;
- Ineligibility for MRI according to the protocol of the local radiology
department;
- Pregnancy;
- Radiotherapy as neoadjuvant treatment;
- >= 1 cm extensive tumor growth into the lumen of healthy hollow organs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acute radiotherapy induced toxicity grade >=4.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of life; non-dose limiting radiation induced toxicity grade 2 and 3;<br /><br>late radiation induced toxicity grade >=3; freedom from local progression.</p><br>