A Phase II Trial of Intermediate Radiation Dose For Lymphoma

NCT ID: NCT05284825

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Follicular Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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12 Gy in 6 daily fractions

Group Type EXPERIMENTAL

12 Gy in 6 daily fractions

Intervention Type RADIATION

12 Gy in 6 daily fractions

Interventions

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12 Gy in 6 daily fractions

12 Gy in 6 daily fractions

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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May Tsao, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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May Tsao, MD

Role: CONTACT

(416) 480-4806

Facility Contacts

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Prasha Sasitharakumar

Role: primary

905 480 500 ext. 7937

Other Identifiers

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3744

Identifier Type: -

Identifier Source: org_study_id

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