A Phase II Trial of Intermediate Radiation Dose For Lymphoma

Not Applicable

Recruiting

• Conditions: Follicular Lymphoma
• Interventions: Radiation: 12 Gy in 6 daily fractions

• Registration Number: NCT05284825
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-28
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-17
• Status Verified: 2023-04
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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)

Read More

Exclusion Criteria

• Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy
• Prognosis less than 3 months
• Pregnancy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
12 Gy in 6 daily fractions	12 Gy in 6 daily fractions	-

Primary Outcome Measures

Name	Time	Method
Complete response within the radiated volume at 1month post radiation	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 Outcome Measures

Name	Time	Method
Overall survival, progression-free survival and toxicity	1 month and 3 month	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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada