A Phase II Trial of Intermediate Radiation Dose For Low Grade Follicular Lymphoma
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Complete response within the radiated volume at 1month post radiation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
12 Gy in 6 daily fractions
Intervention: 12 Gy in 6 daily fractions (Radiation)
Outcomes
Primary Outcomes
Complete response within the radiated volume at 1month post radiation
Time Frame: 1 month
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
Secondary Outcomes
- Overall survival, progression-free survival and toxicity(1 month and 3 month)