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A Phase II Trial of Intermediate Radiation Dose For Lymphoma

Primary Purpose

Follicular Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
12 Gy in 6 daily fractions
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

12 Gy in 6 daily fractions

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 10, 2022
Last Updated
April 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05284825
Brief Title
A Phase II Trial of Intermediate Radiation Dose For Lymphoma
Official Title
A Phase II Trial of Intermediate Radiation Dose For Low Grade Follicular Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12 Gy in 6 daily fractions
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
12 Gy in 6 daily fractions
Intervention Description
12 Gy in 6 daily fractions
Primary Outcome Measure Information:
Title
Complete response within the radiated volume at 1month post radiation
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Overall survival, progression-free survival and toxicity
Description
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.
Time Frame
1 month and 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
May Tsao, MD
Phone
(416) 480-4806
Email
may.tsao@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May Tsao, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasha Sasitharakumar
Phone
905 480 500
Ext
7937
Email
prasha.sasitharakumar@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
May Tsao

12. IPD Sharing Statement

Learn more about this trial

A Phase II Trial of Intermediate Radiation Dose For Lymphoma

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