A Phase II Trial of Intermediate Radiation Dose For Lymphoma

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Follicular Lymphoma

Treatments: Radiation: 12 Gy in 6 daily fractions

Study type: Interventional

Funder types: Other

Identifiers

NCT05284825

3744

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

12 Gy in 6 daily fractions

Experimental group

Treatment:

Radiation: 12 Gy in 6 daily fractions