Perfexion Brain Metastasis

NCT00805103 | Terminated Phase 1 DMC

• 1 other identifier: UHN REB 08-0602-C
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Brain metastases occur in 20% to 40% of all patients with cancer , with an incidence 10 times higher than that of primary malignant brain tumors. Patients with brain metastases have a poor prognosis with a median survival of 1-2 months with corticosteroids and 5-7 months with whole brain radiotherapy (WBRT). Local control achieved with WBRT in patients with otherwise controlled systemic disease remains at issue. A single high dose of radiation delivered with high precision to the target lesion (Stereotactic radiosurgery (SRS)), is considered standard care in salvage of recurrent lesions after WBRT. SRS can destroy tumour with very little damage to surrounding tissue. Research suggests that delivering radiotherapy in a number of smaller doses is more beneficial than receiving all of the radiotherapy in a single dose. Brain metastases are well suited for SRS as they are often small, radiographically well-circumscribed, pseudospherical tumors that are noninfiltrative.

Conditions

Brain Metastases

Keywords

Brain Metastases; Stereotactic radiosurgery (SRS); Hypofractionated stereotactic radiotherapy (HSRT); Recurrent Brain Metastases

Outcome Measures

Primary Outcomes (1)

• This study aims to determine what the maximum tolerated dose of hypofractionated adaptive stereotactic radiotherapy (HFA-SRT) for recurrent brain metastases is.

  every 3 months for 3 years

Secondary Outcomes (2)

• The secondary outcome will be to evaluate the overall survival and change in tumour response.

  every 3 months for 3 years

• Measure acute and late toxicities

  every 3 months for 3 years

Study Arms (1)

(HFA-SRT) in Large-Volume Brain Metastases

EXPERIMENTAL

Radiation: Hypofractionated stereotactic radiotherapy

Interventions

Hypofractionated stereotactic radiotherapy RADIATION

Patients will be initially administered 8 Gy RT (level). The dose at each level will be increase by 2 Gy up to level 4. If ≥ 2 of the patients in a dose cohort encounter a DLT, then that dose level will be declared the maximum administered dose. An additional 3 patients will then be entered at the previous dose level and provided no more than one patient experiences a DLT, that level will be declared the maximum tolerated dose (MTD). Up to 6 more patients can be treated at the given dose level while awaiting the results of 6 months of follow-up.

(HFA-SRT) in Large-Volume Brain Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• recurrent brain metastases after WBRT, and
• At least 1 lesions \>2cm in maximum diameter
• ECOG 0-2
• Life expectancy \>3months
• Age ≥ 18 years old

You may not qualify if:

• Edentulous patients
• Prior surgery or injury to hard palate
• Severe claustrophobia
• Contraindication to MRI
• Contraindication to IV contrast (Gadolinium) administration
• Other medical conditions that would preclude study investigations
• Prior radiosurgery to recurrent lesions
• Radiation cannot be delivered at the assigned dose level in a manner that respects OAR constraints (3.2.2.4.2.3.4) (e.g. lesions within brainstem or abutting optic structures)
• Any lesion \>5cm in diameter, or total volume of tumor \> 60cc
• Pregnant Women
• Men or women of childbearing potential who are unwilling to employ adequate contraception

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Caroline Chung, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

CA (1)