Hypofractionated Brain Radiationcavity

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03561896
• Date of registration: 19/01/2017
• Prospective Registration: No
• Primary sponsor: Oncology Institute of Southern Switzerland
• Public title: Hypofractionated Brain Radiationcavity
• Scientific title: Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial
• Date of first enrolment: January 2015
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03561896
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy, Switzerland

Contacts

• Name: Gianfranco A Pesce, MD
• Affiliation: IOSI, Bellinzona, Switzerland

Key inclusion & exclusion criteria

Inclusion criteria:

- Patient underwent surgery for single brain metastasis arising from solid neoplasia
(lung, breast, melanoma, kidney, colorectal), with initial histological diagnosis, or
selected cases with a resected lesion and a further non-resected lesion (from 1 to 2
lesions), treatable with SRS / IGRT of the surgical cavity

- Patient = 18 years

- Willngness to participate in the study, written informed consent

- Performance Status according to WHO 0-I

- Good general conditions and organ function

- Newly diagnosed chemotherapy-naïve disease or controlled systemic disease

- Good bone marrow, renal and hepatic function

- Stable steroid dose or reduced for at least 5 days

Exclusion Criteria:

- History of previous brain irradiation

- Pregnancy or breastfeeding

- Histological diagnosis other than lung, breast, melanoma, kidney and colorectal
malignancy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Brain Metastases, Adult

Cancer Brain

Intervention(s)

Radiation: IGRT

Radiation: SRS

Primary Outcome(s)

Relapse rate [Time Frame: 1 year]

Secondary Outcome(s)

Time to systemic progression [Time Frame: 1 year]

Time to neurological progression [Time Frame: 1 year]

Overall survival [Time Frame: 1 year]

Quality of life assessment [Time Frame: 1 year]

Secondary ID(s)

IOSI-RTO-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors