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Neoadjuvant and postoperative treatment with dabrafenib and trametinib for papillary craniopharyngioma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517611-67-00
Acronym
Swecranio1-21
Enrollment
25
Registered
2024-10-18
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-18

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

Conditions

papillary craniopharyngioma

Brief summary

To evaluate tumour response measured as reduction in tumour volume on MRI for patients with papillary craniopharyngioma on treatment with dabrafenib and trametinib.

Detailed description

To evaluate treatment with dabrafenib and trametinib for the following aspects: - response according to RECIST - response duration for patients who are treated without subsequent surgery - number of patients that become operable after neoadjuvant treatment - progression free survival after 1 and 2 years - quality of life during and after treatment - the effect of treatment on vision, cognition and hypothalamic function

Interventions

DRUGTRAMETINIB
DRUGDABRAFENIB

Sponsors

Region Skane
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To evaluate tumour response measured as reduction in tumour volume on MRI for patients with papillary craniopharyngioma on treatment with dabrafenib and trametinib.

Secondary

MeasureTime frame
To evaluate treatment with dabrafenib and trametinib for the following aspects: - response according to RECIST - response duration for patients who are treated without subsequent surgery - number of patients that become operable after neoadjuvant treatment - progression free survival after 1 and 2 years - quality of life during and after treatment - the effect of treatment on vision, cognition and hypothalamic function

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026