A Phase II Trial of Intermediate Radiation Dose For Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial of Intermediate Radiation Dose For Low Grade Follicular Lymphoma

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Radiation: 12 Gy in 6 daily fractions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years or older Pathology review at Sunnybrook Health Sciences Centre showing low grade (grade 1- 2) follicular lymphoma Previously un-irradiated stages I-IV low grade follicular lymphoma Radiation indicated for local disease control (radical or palliative) Able to give informed consent Non-bulky targets (less than 7cm) Exclusion Criteria: Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy Prognosis less than 3 months Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 Gy in 6 daily fractions<br> | Radiation: 12 Gy in 6 daily fractions<br>* 12 Gy in 6 daily fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation