Radiotherapy for Eye Cancer

Overseen By Sandy Chang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must not be taking: Systemic therapy

Disqualifiers: Aggressive NHL, Prior RT, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new radiation therapy approach for individuals with indolent B-cell orbital lymphoma, a type of eye cancer. The goal is to balance effective cancer control with reduced side effects. The study tests whether 12Gy of radiation in 6 sessions can control the disease better and with fewer side effects than higher doses. Suitable participants include those with confirmed indolent lymphoma in one or both eyes who have not previously received radiation treatment to the eye. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot have systemic therapy for lymphoma from two weeks before starting radiotherapy until two weeks after completing it.

What prior data suggests that this radiotherapy protocol is safe for eye cancer?

Research has shown that external beam radiation therapy (EBRT) is generally safe for treating eye cancer. One study found that EBRT successfully prevented cancer recurrence in 98% of patients over five years. However, some long-term side effects were noted: 16% of patients experienced dry eyes, and 13% developed cataracts, where the lens of the eye becomes cloudy.

Another study found no cancer recurrence in patients who received this type of radiation and reported good survival rates without significant early or late side effects. These findings suggest that EBRT is well-tolerated, making it a promising option for those considering treatment for eye cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using external beam radiation therapy for eye cancer, specifically low-grade orbital lymphoma, because it offers a targeted approach with potentially fewer side effects. Unlike some traditional treatments like chemotherapy or surgery, this method uses precise radiation volumes to minimize damage to surrounding healthy tissue. Additionally, the treatment regimen of 12 Gy in 6 fractions is designed to be efficient, potentially leading to shorter treatment times and improved patient convenience. This innovative approach could provide a more focused and less invasive alternative to existing therapies.

What evidence suggests that 12 Gy in 6 fractions of external beam radiation therapy is effective for eye cancer?

Research has shown that using a 12Gy dose in four sessions for radiation therapy in various body areas is promising, effectively controlling the disease with few side effects. In this trial, participants will receive 12 Gy in six fractions of external beam radiation therapy, designed to be both effective and safe for low-grade orbital lymphoma. Currently, higher doses of 24-25Gy control the disease well but can lead to long-term side effects like cataracts. The 12Gy in six sessions aims to improve disease control compared to the very low dose of 4Gy, which is less effective but has minimal side effects. This new method might offer a balance, enhancing results while minimizing side effects. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with indolent B-cell orbital lymphoma, a type of eye cancer. It's designed to find a balance between effective treatment and minimizing side effects. Participants should not have received the current standard radiation therapy doses for this condition.

Inclusion Criteria

Able to provide informed consent

I am willing to fill out questionnaires about my health online or on paper.

I am 18 or older with a slow-growing type of non-Hodgkin lymphoma.

Exclusion Criteria

I have had radiation therapy to my eye area.

I haven't had lymphoma treatment 2 weeks before or after radiation.

Patients requiring treatments outside standard clinical hours

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive 12 Gy in 6 fractions of external beam radiation therapy for low-grade orbital lymphoma

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• External Beam Radiation Therapy

Trial Overview The study tests a new radiation therapy regimen: 12Gy delivered in 6 fractions. This approach aims to improve disease control compared to ultra-low dose treatments while reducing long-term toxicities associated with higher doses typically used.

How Is the Trial Designed?

Group I: 12 Gy in 6 fractions of external beam radiation therapy Experimental Treatment 1 Intervention

12 Gy in 6 fractions of conventional external beam radiation therapy using standard-of-care radiation volumes for low-grade orbital lymphoma

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9637715/

Radiation therapy for primary orbital and ocular adnexal ... External Beam Radiotherapy, with lens shielding whenever indicated, at a dose of 20–30 Gy delivered over 10–20 fractions is an efficacious and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301605004177

Radiation therapy for orbital lymphoma The 5-year disease-specific and overall survival rates were 95% and 88%, respectively. Late toxicity was mainly cataract formation in patients who received ...

3. clinicaloncologyonline.net clinicaloncologyonline.net/article/S0936-6555(14)00376-8/pdf

Outcomes of Primary Lymphoma of the Ocular Adnexa ( ... Results: In total, 81 patients and 85 orbits were treated with primary radiotherapy to a median dose of 30 Gy in 15 fractions over 3 weeks.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2821030

Response-Adapted Ultralow-Dose Radiation Therapy for ... In a retrospectively analyzed group, the novel ULD response-adapted strategy led to a 2-year local control rate of 96.3%, with most patients ...

5. 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 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S093665552200070X

Treatment Outcomes of Low-grade Lymphoma of the Orbit There were no local recurrences in patients receiving external beam radiation. •. Recurrence free survival in stage IVE (bilateral) patients is improved with ...

7. mdpi.com mdpi.com/2072-6694/15/24/5782

Radiotherapy of Orbital and Ocular Adnexa Lymphoma Five-year local control rates with radiotherapy alone in the treatment of OAL range from 89 to 100%, as reported by several studies [6,16,21,31 ...

8. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-022-02180-6

Ultra-low-dose radiotherapy in the treatment of ocular adnexal ... Ultra-low-dose radiotherapy in patients with OAL is associated with excellent local disease control and long-term survival with no significant acute or late ...