Finding the maximum tolerated dose for MRI guided radiotherapy on upper abdomen malignancies in particular pancreatic malignancies.
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acute radiotherapy induced toxicity grade >=4.
Secondary outcome
Quality of life; non-dose limiting radiation induced toxicity grade 2 and 3;
late radiation induced toxicity grade >=3; freedom from local progression.
Background summary
Primary malignancies in the upper abdomen, such as pancreatic, cholangio-, and
periampullary carcinomas, are often diseases that are associated with a poor
prognosis. This is even more true for patients who are diagnosed with locally
advanced disease and for patients that show a recurrence after resection.
Modern systemic therapy regimens have significantly improved control of
micrometastatic disease. However, local destructive progression is still a
major cause of death, stressing the need for better local therapies.
Our group has demonstrated that an irradiation dose of 40 Gy in 5 fractions can
be safely delivered in the upper abdomen without severe toxicities using MR
guided radiotherapy (MRgRT). However, there is evidence that higher dose levels
are associated with improved outcome in terms of local control and overall
survival.
Study objective
Finding the maximum tolerated dose for MRI guided radiotherapy on upper abdomen
malignancies in particular pancreatic malignancies.
Study design
A single-center phase I dose finding trial on dose-escalated MRI guided
radiotherapy. The study will be conducted using a rolling six single-arm
open-label design.
Intervention
Higher dose with MRI guided radiotherapy applied in three dose levels.
Study burden and risks
Tthe chance exists that the patient has a higher risk on developing radiation
induced toxicity.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78766.041.21 |