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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52302

Enrollment

Registered

2021-12-31

Start date

2022-04-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic malignancies - Pancreatic tumors

Interventions

Higher dose with MRI guided radiotherapy applied in three dose levels.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Age = 1 cm extensive tumor growth into the lumen of healthy hollow organs.

Design outcomes

Primary

Measure	Time frame
Acute radiotherapy induced toxicity grade >=4.	—

Secondary

Measure	Time frame
Quality of life; non-dose limiting radiation induced toxicity grade 2 and 3; late radiation induced toxicity grade >=3; freedom from local progression.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)