A Phase II Trial of Intermediate Radiation Dose For Lymphoma
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2022
CompletedFirst Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedFebruary 15, 2024
April 1, 2023
2.8 years
March 10, 2022
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Overall survival, progression-free survival and toxicity
1 month and 3 month
Study Arms (1)
12 Gy in 6 daily fractions
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- ≥ 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)
You may not qualify if:
- Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy
- Prognosis less than 3 months
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
May Tsao, MD
Sunnybrook Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 17, 2022
Study Start
February 28, 2022
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
February 15, 2024
Record last verified: 2023-04