Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction SBRT Regimen, for Extra-Cranial Oligometastases
This is a prospective Phase II study. The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule.
The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study on the Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction Stereotactic Body Radiation Therapy (SBRT) Regimen, for Extra-Cranial Oligometastases|
- Proportion of patients with lack of progressive disease for the index site at 1 year [ Time Frame: 10 years ] [ Designated as safety issue: No ]CT will be used for evaluation of the status of the local disease at the index site.
- Number of index lesion(s) with lack of progressive disease at 1 year. [ Time Frame: 10 years ] [ Designated as safety issue: No ]The Modified Response Evaluation Criteria for solid Tumors (RECIST) will be used. By measuring the longest diameter (LD) of the lesions, response of individual lesions and overall response will be documented.
- Acute toxicity within 90 days of first fraction of radiotherapy, and late toxicity occuring beyond 90 days related to SBRT. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]Acute toxicity will be graded according to the Common Toxicity Criteria, v3.0, and late toxicity evaluated according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score.
- Time to local progression for the index site(s) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Time to distant disease progression (beyond known sites of oligometastases at time of study entry) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2022|
|Estimated Primary Completion Date:||March 2022 (Final data collection date for primary outcome measure)|
5 Fractions SBRT (daily) Max 40Gy (8Gy/fraction) at isocentre, 90% Planning Target Volume (PTV) coverage, max 130% within Gross Tumour Volume (GTV)
This is a prospective Phase II study. The purpose of this study is to examine the safety and efficacy of tumor control effect of a 5-fraction stereotactic body radiotherapy (SBRT) regimen for any metastatic location. Endpoints are to describe: the proportion of patients with local control for the index site at 1 year; the number of index lesion(s) with local control at 1 year; acute and late AEs related to SBRT; time to local progression for the index site; time to distant disease progression; symptom and QoL profile; median survival.
|Contact: Rebecca Wong, MD||416-946-4501 ext 2126|
|University Health Toronto||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator: Rebecca Wong, MD|
|Principal Investigator:||Rebecca Wong, MD||University Health Network - Princess Margaret Hospital|