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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well ultra low-dose radiation therapy works in treating patients with stage I-IV stomach mucosa-associated lymphoid tissue (MALT) lymphoma. Ultra low-dose radiation therapy may be able to kill tumor cells and shrink tumors while having fewer side effects in patients with MALT lymphoma.

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 data supports the effectiveness of the treatment Ultra Low-Dose Radiation Therapy for Gastric Lymphoma?

Research shows that ultra-low dose radiation therapy has been effective in treating low-grade lymphomas, including those in the stomach, with high rates of complete response and minimal side effects. This suggests it could be a promising treatment for gastric lymphoma as well. ^{1 2 3 4 5}

Is ultra low-dose radiation therapy generally safe for humans?

Radiation therapy for gastric lymphoma has been studied with reduced doses and target areas, showing low toxicities and good survival rates. However, there are potential risks of mild to moderate side effects on nearby organs, such as the liver and bowel, which can include elevated liver enzymes and diarrhea. ^{6 7 8 9 10}

How does ultra low-dose radiation therapy differ from other treatments for gastric lymphoma?

Ultra low-dose radiation therapy uses significantly lower doses of radiation (as low as 4 Gy) compared to traditional treatments, which typically use doses of 24-30 Gy or more. This approach aims to effectively control the lymphoma while minimizing side effects and preserving the stomach, making it a novel option for patients with gastric lymphoma. ^{1 11 12 13 14}

Research Team

Jillian Gunther

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 with scleroderma are ineligible

Patients who are pregnant

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Ultra-low dose radiotherapy in the management of low-grade orbital lymphomas. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Response rates and recurrence patterns after low-dose radiotherapy with 4 Gy in patients with low-grade lymphomas. [2019]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Low grade MALT lymphoma of the stomach: treatment outcome with radiotherapy alone. [2007]

4. Australia pubmed.ncbi.nlm.nih.gov

Value of low-dose 2 x 2 Gy palliative radiotherapy in advanced low-grade non-Hodgkin's lymphoma. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Rationale for radiotherapy as a treatment modality in gastric mucosa-associated lymphoid tissue lymphoma. [2007]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Radiation-induced damage in the upper gastrointestinal tract: clinical presentation, diagnostic tests and treatment options. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

Outcome of radiotherapy for gastric mucosa-associated lymphoid tissue lymphoma refractory to Helicobacter pylori eradication therapy. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Biophysical Analysis of Acute and Late Toxicity of Radiotherapy in Gastric Marginal Zone Lymphoma-Impact of Radiation Dose and Planning Target Volume. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Radiotherapy in Early-stage Gastric MALT: Improved Survival Without Increased Cardiac Death. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Radiation-Induced Liver Injury in Three-Dimensional Conformal Radiation Therapy (3D-CRT) for Postoperative or Locoregional Recurrent Gastric Cancer: Risk Factors and Dose Limitations. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Radiation therapy for unresected gastric lymphoma]. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Low-dose induction radiotherapy for stomach conservation in patients with massive gastric lymphoma. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Development of Organ-Preserving Radiation Therapy in Gastric Marginal Zone Lymphoma. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Outcomes After Reduced-Dose Intensity Modulated Radiation Therapy for Gastric Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma. [2020]