ocally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy (LAPSTAR) - a Randomized Controlled Trial

Conditions: locally advanced pancreatic carcinoma
pancreatic cancer
10027656

Registration Number: NL-OMON56693

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 156

Inclusion Criteria

- Pathology proven pancreatic ductal adenocarcinoma (PDAC);
- At least two (preferably four) months systemic therapy with (m)FOLFIRINOX
and/or gemcitabine + nab-paclitaxel; or eligibility for chemotherapy but no
initiation of chemotherapy based on patients* wish;
- No option for surgical resection, either because anatomical irresectability
based on the surgeon*s judgement (assessed on imaging or during explorative
laparotomy) and/or frailty (unfit for surgery or chemotherapy) and/or no
surgery based on patient's wish.
- No evidence of distant metastatic disease progression, evaluated by CT Thorax
/ Abdomen / Pelvis and/or PET-CT scan;
- Performance status WHO 0-2.

Exclusion Criteria

- Contra-indications for MRI or CT with an intravenous contrast agent according
to the protocol of the local radiology and/or radiotherapy departments
- Contraindications for MRgRT, as determined by the involved expert radiation
oncologists of the Consortium
- <18 years old
- Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is health-related quality of life deterioration-free<br /><br>survival, defined as the Time Until Definitive<br /><br>Deterioration (TUDD) including death from any cause, calculated from the time<br /><br>of randomization.<br /><br><br /><br><br /><br>HRQoL is primarily assessed using the EORTC QLQ-C30 (version 3.0) Summary<br /><br>Score. TUDD is defined as a definitive deterioration of >=10 points on Summary<br /><br>Score (with no further improvement of >=10 points afterwards) or death from any<br /><br>cause are considered an event. HRQoL is assessed longitudinally at inclusion<br /><br>(baseline, prior to MRgRT), after two weeks, after four weeks and every<br /><br>subsequent two months until end of study follow-up or death.</p><br>

Secondary Outcome Measures