Ultra Low-Dose Radiation Therapy for Gastric Lymphoma

Overseen By Jillian Gunther, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Aggressive B cell lymphoma, Bulky tumors, Prior stomach radiation, Pregnancy, Scleroderma, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ultra low-dose radiation therapy can effectively treat stomach lymphoma, specifically MALT lymphoma, with fewer side effects. It aims to determine if this low-dose approach can shrink tumors and kill cancer cells in patients with stage I-IV stomach MALT lymphoma. Individuals who have tested negative for H. pylori (a stomach bacteria) in the past six months and have biopsy-proven lymphoma in the stomach might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that planned systemic therapy (treatment affecting the whole body) is allowed, and necessary antibiotics for unrelated reasons are permitted.

What prior data suggests that ultra low-dose radiation therapy is safe for treating gastric lymphoma?

Research shows that ultra low-dose radiation therapy is usually manageable for patients with MALT lymphoma. Studies have found that patients often experience mild side effects, with mild nausea being the most common, affecting about 38% of those receiving 4 Gy of radiation. Importantly, no serious side effects have been reported.

These findings suggest that the treatment is generally safe and well-tolerated, making it a promising option for those with this type of lymphoma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ultra Low-Dose Radiation Therapy is unique because it uses significantly lower doses of radiation compared to traditional radiation treatments for gastric lymphoma. This approach aims to minimize side effects while still effectively targeting cancer cells. Researchers are excited about this treatment because it could potentially offer a safer and less toxic alternative to standard high-dose radiation therapy, making it a promising option for patients who are sensitive to the harsh effects of conventional treatments. Additionally, the rapid delivery over just two consecutive days is a notable advantage, potentially leading to quicker recovery times and less disruption to patients' lives.

What evidence suggests that ultra low-dose radiation therapy might be an effective treatment for gastric lymphoma?

Research has shown that ultra low-dose radiation therapy, which participants in this trial will receive, can be very effective for treating MALT lymphoma, a type of stomach cancer. One study found that 83% of patients had a complete response, with tumors either shrinking significantly or disappearing after receiving a small dose of 4 Gy radiation. This low-dose method aims to kill cancer cells and reduce tumor size while minimizing side effects. Another study reported excellent results, with no cases of the cancer worsening after treatment. These promising findings suggest that ultra low-dose radiation therapy could be a strong option for those with MALT lymphoma. ^{2 5 6 7 8}

Who Is on the Research Team?

Jillian Gunther

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with stage I-IV stomach MALT lymphoma, who have tested negative for H. pylori within 6 months and are not pregnant. It's open to those who haven't had prior radiation that would exceed safe levels upon re-treatment and don't have aggressive B cell lymphoma or bulky tumors over 10 cm.

Inclusion Criteria

Patients must have H. pylori testing which is negative within 6 months prior to treatment

I am 18 or older with a specific type of stomach cancer.

My stomach cancer has been confirmed with a biopsy.

Exclusion Criteria

My condition is aggressive B cell lymphoma, such as DLBCL or grade 3 follicular lymphoma.

Patients who are pregnant

Patients with scleroderma are ineligible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo low-dose radiation therapy over 2 fractions for 2 consecutive days

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Ultra Low-Dose Radiation Therapy

Trial Overview

The study is testing ultra low-dose radiation therapy on patients with stomach MALT lymphoma to see if it can effectively shrink tumors and kill cancer cells while minimizing side effects compared to traditional doses.

How Is the Trial Designed?

Group I: Treatment (low-dose radiation therapy) Experimental Treatment 1 Intervention

Patients undergo low-dose radiation therapy over 2 fractions for 2 consecutive days in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease at 12-16 weeks post-treatment, or persistent disease at 1 year may undergo higher-dose radiation therapy at the discretion of treating physician.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 7 patients with low-grade orbital lymphomas treated with ultra-low dose radiotherapy (ULDRT), there was a remarkable local control rate of 100%, with 71% achieving a complete response after a median follow-up of 22 months.

The treatment was associated with minimal toxicity, with only mild side effects like dry eye and pruritus reported, making ULDRT a promising option for managing indolent orbital lymphomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-low dose radiotherapy in the management of low-grade orbital lymphomas. de Castro, B., Peixeiro, RP., Mariz, JM., et al.[2022]

In a retrospective case series of 10 patients with advanced-stage low-grade non-Hodgkin's lymphoma, low-dose radiotherapy (2 x 2 Gy) resulted in high response rates, with 70% achieving complete response and 20% achieving partial response.

The treatment was well-tolerated, with minimal toxicity observed (no toxicity greater than grade 1), suggesting that low-dose radiotherapy is a safe and effective option for managing local symptoms in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of low-dose 2 x 2 Gy palliative radiotherapy in advanced low-grade non-Hodgkin's lymphoma. Ng, M., Wirth, A., Ryan, G., et al.[2018]

In a study of 32 patients with gastric MALT lymphoma, radiation therapy (RT) at a reduced dose of 24 Gy resulted in a complete response in all patients, demonstrating its efficacy compared to the standard dose of ≥30 Gy.

The outcomes for freedom from local treatment failure (FFLTF), freedom from treatment failure (FFTF), and overall survival (OS) were excellent for both the 24 Gy and ≥30 Gy groups, indicating that lower doses may be just as effective as higher doses in achieving disease control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes After Reduced-Dose Intensity Modulated Radiation Therapy for Gastric Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma. Pinnix, CC., Gunther, JR., Milgrom, SA., et al.[2020]

Low-dose radiotherapy (LDRT) demonstrated a high overall response rate of 90% in treating low-grade lymphomas, with a median follow-up of 21 months, indicating its effectiveness as a primary treatment option.

LDRT was well-tolerated with no acute or long-term side effects reported, making it a safe treatment choice for patients, particularly those with smaller tumors (≤5 cm) and fewer previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response rates and recurrence patterns after low-dose radiotherapy with 4 Gy in patients with low-grade lymphomas. König, L., Hörner-Rieber, J., Bernhardt, D., et al.[2019]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38843856/

Response-adapted ultra-low-dose 4 Gy radiation as ... - PubMed

20 patients (83%) had a complete response to 4 Gy (16 at 3-4 months, four at 9-13 months); two patients received 20 Gy for symptomatic stable ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2352302624001339

Response-adapted ultra-low-dose 4 Gy radiation as ...

Our data suggest that 83% of patients had a complete response to the initial dose of 4 Gy.

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advancesradonc.org

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Ultra–Low-Dose Radiation for Extranodal Marginal Zone ...

Conclusions. Patients with lung MALT experienced excellent outcomes following RA-ULDRT, with 100% LC after 4 Gy and no patients requiring ...

4.

redjournal.org

redjournal.org/article/S0360-3016(24)03513-2/abstract

Reduced-dose Radiation Therapy for Stage IE Gastric ...

The 6-month CR rate was 96.7%. The 5-year local failure-free survival and progression-free survival rates were 92.0% and 90.4%, respectively.

5.

advancesradonc.com

advancesradonc.com/article/S2452-1094(21)00072-5/pdf

Comparable Efficacy of Reduced Dose Radiation Therapy ...

Abstract Purpose: This study compares reduced (<27 Gy) to standard dose (≥30 Gy) radiation therapy (RT) in the treatment of gastric extranodal marginal zone ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6839887/

Associated Lymphoid Tissue (MALT) Lymphoma - PMC

The 2-year freedom from local treatment failure rate was 100% and 2-year overall survival was 97%.

7.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2821030

Response-Adapted Ultralow-Dose Radiation Therapy for ...

No grade 3 or higher toxic effects were observed. In a planned subset analysis of 22 patients with newly diagnosed, untreated stage I mucosa- ...

8.

wjon.org

wjon.org/index.php/wjon/article/view/1846/1618

Definitive Radiotherapy for Stage I Gastric Mucosa-Associated ...

The 5-year overall survival, local control survival, and disease-free survival rates were 100%, 100%, and 97.7%, respectively. No severe acute adverse events ...