Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma.
It is hypothesized that the complete response rate with the use of 12 Gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months.
This phase II study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 Gy in 6 daily fractions | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 Gy in 6 daily fractions | Radiation | 12 Gy in 6 daily fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response within the radiated volume at 1month post radiation | Participants will be assessed for response at 1 month (primary outcome) and then 3 months following completion of radiotherapy, clinically or radiographically, as appropriate. Complete response is defined as absence of detectable disease in the radiated volume. Partial response is 50% or more reduction in the volume of disease in the radiated volume. Overall response is defined as complete and partial response. Stable disease is defined as no change in the irradiated tumour or less than 50% reduction. Progressive disease is defined as enlargement of the irradiated tumour | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, progression-free survival and toxicity | Toxicity (6) will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) definitions (site specific modules), at 1 month and then 3 months following completion of radiotherapy. | 1 month and 3 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| May Tsao, MD | Contact | (416) 480-4806 | may.tsao@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| May Tsao, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |