Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Princess Margaret Hospital, Canada | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance | Radiation | All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with lack of progressive disease for the index site at 1 year | CT will be used for evaluation of the status of the local disease at the index site. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of index lesion(s) with lack of progressive disease at 1 year. | 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. | 10 years |
| Acute toxicity within 90 days of first fraction of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Explore pre-treatment prognostic factors derived from clinical data and correlative studies for disease free interval | 10 years | |
| Explore pre-treatment prognostic factors derived from clinical data and correlative studies for local control of index site(s) at 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca K.S. Wong, MB ChB | University Health Network - Princess Margaret Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network, Princess Margaret Cancer Center | Toronto | Ontario | M5G 2M9 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Acute toxicity will be graded according to the Common Toxicity Criteria, v4.0 |
| 10 years |
| Time to local progression for the index site(s) | 10 years |
| Time to distant disease progression (beyond known sites of oligometastases at time of study entry) | 10 years |
| Late toxicity occuring beyond 90 days related to SBRT. | Late toxicity will be graded according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score. | 10 year |
| Describe symptom profile | 10 Years |
| Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities | 10 years |
| 10 years |
| ID | Term |
|---|---|
| C499330 | MAX protein, human |
Not provided
Not provided
Not provided