Recruiting

Intermediate Radiation Dose

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05284825

Conditions

Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

12 Gy in 6 daily fractions

Study Details

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.

Conditions

Follicular Lymphoma

Study ID

NCT05284825

Start date

Feb 28, 2022

Status verified date

Apr, 2023

Completion date

Jan 1, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 12 Gy in 6 daily fractions

Interventions

12 Gy in 6 daily fractions

12 Gy in 6 daily fractions

Primary outcome measure

  • Complete response within the radiated volume at 1month post radiation [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

May Tsao, MD

(416) 480-4806may.tsao@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Prasha Sasitharakumar

905 480 500prasha.sasitharakumar@sunnybrook.ca

Principal Investigator:

May Tsao

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Feb 15, 2024

Last verified

Apr, 2023

Keywords

  • radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-02-15.