A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases (TOMOSIBII)

A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases

Helical tomotherapy is a novel radiation treatment machine that combines two existing technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy imaging of the body. This new machine can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with existing radiation machines. In this study, helical tomotherapy will be used to provide radiation treatments (whole brain radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to the brain. In addition, the individual spots of cancer (metastases) in the brain will be treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. The purpose of this study is to determine the effectiveness of whole brain radiation with lesion boosting with the helical tomotherapy machine.

Study Overview

• Status: Completed
• Conditions: Metastasis to Brain of Primary Cancer
• Intervention / Treatment: Radiation: Whole Brain XRT 30Gy/10 fractions with

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Alberta Health Services, Cross Cancer Institute
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program of the Lawson Health Research Institute
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Centre
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histological diagnosis of primary cancer
• Contrast enhanced MRI demonstrating 1-3 metastases within 6 weeks of enrollment
• Age greater than or equal to 18
• Karnofsky performance status greater than or equal to 70
• Patient available for subsequent follow-up appointments and testing as well as health-related quality of life questionnaires
• Anticipated survival (independent of the brain metastases) greater than 3 months
• Patient informed consent obtained
• Metastatic suitable for synchronous boost
• Extracranial disease controlled or to be treated

Exclusion Criteria:

• Underlying medical condition precluding adequate follow-up
• Prior cranial radiotherapy
• Concurrent cytotoxic chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Radiation Therapy Treatment; Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy	Radiation: Whole Brain XRT 30Gy/10 fractions with; 30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	At approximately end of year 4 (study completion)
Local disease control rate at 6 months	At approximately 2.5 years
CNS disease control rate at 6 months	At approximately 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of RTOG versus RECIST versus Volumetric MRI criteria		At approximately end of year 4 (study completion)
Health related quality of life		At approximately end of year 4 (study completion)
Karnofsky performance status		AT approximately end of year 4 (study completion)
Mini mental status exam cognition		At approximately end of year 4 (study completion)
Acute toxicity		At approximately end of year 4 (study completion)
Late toxicity		At approximately end of year 4 (study completion)
Changes in MRI endpoints	Assessment in changes of diffusional weighted imaging and magnetic resonance spectroscopy. Changes at 3 months post-treatment and 6 months post-treatment will be compared to baseline (pre-treatment).	Measured at baseline, and 3 months and 6 months post-treatment

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Ontario Institute for Cancer Research
• Investigators: Principal Investigator: George Rodrigues, MD, MSc, London Regional Cancer Program of the Lawson Health Research Institute

Publications and helpful links

General Publications

• Rodrigues G, Yartsev S, Tay KY, Pond GR, Lagerwaard F, Bauman G. A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases. Radiat Oncol. 2012 Mar 21;7:42. doi: 10.1186/1748-717X-7-42.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: 1-3 brain metastases from any primary cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: R-10-204; 16776 (Other Identifier: Research Ethics Board)