Radiation Therapy for Follicular Lymphoma

Overseen By May Tsao, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Steroids

Disqualifiers: Systemic therapy, Prognosis < 3 months, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the optimal radiation dose for treating low-grade follicular lymphoma, a type of blood cancer. Researchers aim to assess whether a specific radiation schedule can effectively target the cancer while minimizing side effects. Individuals diagnosed with non-bulky (less than 7 cm) follicular lymphoma who have not previously received radiation may be eligible to participate. The treatment consists of radiation administered in six sessions over a few days (12 Gy in 6 daily fractions). As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance future treatment options for patients with similar conditions.

Will I have to stop taking my current medications?

The trial requires that you do not take systemic therapy (like chemotherapy or steroids) for lymphoma within 3 months before or after the radiation treatment.

What prior data suggests that this radiation therapy regimen is safe for follicular lymphoma?

Research has shown that using 12 Gy in six daily treatments for follicular lymphoma is safe. Studies on similar treatments, such as 12 Gy in four sessions, have demonstrated good results for patients with non-Hodgkin lymphoma. These studies report that the treatment is generally well-tolerated, with no major safety concerns, indicating it causes few serious side effects. Overall, this approach appears to be a safe option for managing slow-growing lymphomas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard chemotherapy and immunotherapy treatments for follicular lymphoma, which can take weeks or months to show results, the radiation therapy under study delivers a targeted dose of 12 Gy in just six daily fractions. This approach is unique because it uses a precise radiation dose over a short period, potentially reducing treatment time and side effects while maintaining effectiveness. Researchers are excited about this therapy because it could offer a faster and less burdensome option for patients, making it an appealing alternative to more prolonged treatment regimens.

What evidence suggests that this radiation therapy is effective for follicular lymphoma?

Research has shown that a specific radiation treatment, administered in six daily doses, effectively treats follicular lymphoma. One study found that 95% of the treated areas showed a complete response, meaning the cancer was no longer detectable. This treatment also caused very few side effects, making it a safer choice for patients. The evidence suggests that this radiation method not only controls the cancer effectively but also minimizes side effects, making it a promising option for those with this type of lymphoma. ^{1 2 6 7 8}

Who Is on the Research Team?

May Tsao, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 with low-grade (grade 1-2) follicular lymphoma that hasn't been treated with radiation before. It's for those who need radiation for local disease control, have non-bulky targets under 7cm, and can consent to treatment. Pregnant individuals or those on systemic therapy for lymphoma within the last 3 months are excluded.

Inclusion Criteria

My lymphoma is low grade, stages I-IV, and has not been treated with radiation.

My cancer targets are smaller than 7cm.

My lymphoma is low grade according to Sunnybrook's pathology review.

Exclusion Criteria

My doctor expects I have less than 3 months to live.

I am not pregnant.

I haven't had systemic therapy for lymphoma around my radiotherapy time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive 12 Gy in 6 daily fractions for low grade follicular lymphoma

1 week

6 visits (in-person)

Follow-up

Participants are monitored for response and toxicity at 1 month and 3 months post-radiation

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 12 Gy in 6 daily fractions

Trial Overview The study is testing a specific intermediate dose of radiation (12 Gy in 6 daily fractions) to see if it effectively treats follicular lymphoma while reducing both immediate and long-term side effects. The goal is an excellent response rate with minimal toxicity.

How Is the Trial Designed?

Group I: 12 Gy in 6 daily fractions Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5016012/

Limited Stage Follicular Lymphoma: Current Role of Radiation ... A radiation schedule of 4 Gy in 2 fractions was firstly shown to be highly effective when used for palliation of advanced-stage, relapsing, or even post ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352302625000717

Articles Low-dose moderate hypofractionated radiotherapy ... In this study, 95% of irradiated sites had a complete response to the 12 Gy regimen with a minimal toxicity profile. Our study contributes valuable data on ...

3. thelancet.com thelancet.com/journals/lanhae/article/PIIS2352-3026(25)00071-7/abstract

Low-dose moderate hypofractionated radiotherapy for ... The regimen of 12 Gy in four fractions is safe and shows promising activity as a local treatment for patients with indolent non-Hodgkin lymphoma ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jvc2.403

Ultra‐low dose radiation therapy for primary cutaneous ... Ultra-low dose radiation was associated with high rates of local control and minimal toxicity and may reduce personal burden and financial toxicity.

5. nature.com nature.com/articles/s41408-022-00620-w

Clinical outcomes with use of radiation therapy and risk ... The survival after RT alone from the current study is again excellent, with 62.3% of patients free from treatment failure 5 years after ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07210749

Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma Current standard RT doses (24-25Gy) provide excellent disease control for patients with indolent B-cell orbital lymphoma, but can cause ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11488433/

Maximum disease diameter is associated with outcomes in ... 40.7% of stage II FL patients treated with RT alone remained disease-free at 10 years. Greatest disease diameter >3.6 cm was associated with ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352302625000717/pdf

Articles Low-dose moderate hypofractionated radiotherapy ... The results suggest that the regimen of 12 Gy in four fractions could be a promising regimen for patients with indolent non-Hodgkin lymphoma. The efficacy of ...