Intraoperative Radiotherapy After the Resection of Brain Metastases

Brain Metastases Clinical Trial

— INTRAMET  

Official title:

Intraoperative Radiotherapy After the Resection of Brain Metastases - a Phase II Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03226483
• Other study ID #: 2016-638N-MA
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Universitätsmedizin Mannheim
• Contact: Stefanie Brehmer, MD
• Phone: +49 621 383 2750
• Email: stefanie.brehmer[@]umm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

INTRAMET examines prospectively the effectiveness of an intraoperative radiotherapy immediate after the surgical resection of brain metastases. Patients won't receive further radiation therapy of the intraoperatively treated lesion.

Description:

Brain metastases occur in up to 40% of all patients diagnosed with systemic cancer. Without adjuvant radiotherapy after resection of space occupying lesions local recurrence rates are high. That is why guidelines recommend a cavity boosting with x-rays. External beam radiotherapy can lower the risk of local recurrence but means longer hospitalization, prolongs the time to systemic salvage therapies and bears risks of radionecrosis and leucoencephalopathy with neurological and cognitive decline. A solution for this problem could be onetime intraoperative radiotherapy (IORT) with soft x-rays to sterilize the resection cavity, which may provide both: freedom from local recurrence fast track salvage therapy initiation.

INTRAMET is a single institution, open-label, prospective, phase 2 feasibility study for intraoperative radiotherapy immediately following resection of brain metastases. 50 adult patients with resectable not dural brain metastases should be treated in surgery after tumor resection with IORT with 20-30Gy prescribed to the margin of the resection cavity. The highest dose tolerable to surrounding risk structures (N. opticus, brainstem) should be used.

With this method, the investigators hope to show similar local control rates to postoperative external beam radiotherapy in line with guideline recommendations with less patient hospitalization and faster start of rescue therapies which could lead to a favorable overall outcome and less cognitive side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Karnofsky Performance index = 50%

• MRI T1 Gadolinium enhancing non-dural resectable lesion

• Informed consent

• Adequate birth control

• Frozen section confirms metastasis

• Adequate distance to optic nerve and brainstem

Exclusion Criteria:

• Dural lesions or meningeal carcinomatosis

• Frozen section reveals glioma, lymphoma,small cell lung cancer or germinoma

• Psychiatric or social condition interfering compliance

• Contraindication against anesthesia, surgery, MRI and/or Gadolinium

• Pregnant or breast-feeding women

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Radiation:
• Intraoperative Radiotherapy
Intraoperative Radiotherapy is performed with a mobile radiation device emitting soft energy x-rays in a spherical way. Different size applicators are available to cover the resection cavity after the tightest fit rule.

Locations

Country	Name	City	State
Germany	Universitätsmedizin Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median local progression-free-survival	Rate of recurrence of the treated lesion in the brain	2 years
Secondary	Overall-survival	Survival differentiated between death due to systemic cancer progress and death due to cerebral progress	5 years
Secondary	Time to further therapy	Time to further cancer therapy (e.g. salvage chemotherapy)	6 month
Secondary	Patients cognitive performance	Neuropsychological battery	5 years
Secondary	Patients quality of life	Patient questionary	5 years
Secondary	Global progression-free-survival	Systemic cancer progression-free-survival	2 years
Secondary	Regional progression-free-survival	Progression-free survival concerning other brain metastases	2 years
Secondary	Intraoperative radiotherapy caused dose-limiting toxicities	Occurrence of wound healing disorders or infection requiring surgical revision, cerebral bleeding or ischemia, radionecrosis requiring surgical intervention	6 month after intervention