A Phase II Trial of Intermediate Radiation Dose For Lymphoma

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05284825
• Other study ID #: 3744
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: May Tsao, MD
• Phone: (416) 480-4806
• Email: may.tsao[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Radiation:
• 12 Gy in 6 daily fractions
12 Gy in 6 daily fractions

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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