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Gastric Mucosa-Associated Lymphoid Tissue LymphomaEarly Phase 1NCT03680586

Ultra Low-Dose Radiation Therapy in Treating Patients With Stage I-IV Stomach MALT Lymphoma

A Early Phase 1 study testing Radiation Therapy in people with Gastric Mucosa-Associated Lymphoid Tissue Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
4 Feb 2019to 30 Apr 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18 years or older with stage I-IV MALT lymphoma involving the stomach. Other low grade lymphomas including follicular grade I/II and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible
  • Patients must have biopsy-proven disease within the stomach. Patients with clinical and/or radiographic masses will have dimensions noted prior to therapy
  • Patients must have H. pylori testing which is negative within 6 months prior to treatment
  • Female patients of childbearing potential must have a negative serum pregnancy test (human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry
  • Planned systemic therapy prior to, during, or after gastric radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of systemic therapy
  • Patients must have the ability to give informed consent
  • Necessary treatment with antibiotics for reasons unrelated to gastric lymphoma is permitted however the timing and nature of the treatment will be recorded

Who cannot join

  • Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma
  • Patients with other histologic subtypes of low grade lymphoma (other than MALT) including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or follicular lymphoma
  • Patients with bulky tumors > 10 cm in any dimension
  • Patients with a history of prior radiation to the stomach if re-treatment would exceed known gastric or surrounding critical structure (e.g., bowel, spinal cord) tolerance
  • Patients who are pregnant
  • Patients with scleroderma are ineligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Gastric MALT Lymphoma

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the efficacy of ultra-low dose 4 Gy gastric radiation, measured as complete gastric response at one year after 4 Gy treatment in patients with marginal zone lymphoma involving the stomach (mucosa-associated lymphoid tissue [MALT]).

SECONDARY OBJECTIVES:

  1. To evaluate distant recurrence of marginal zone lymphoma at one year. II. To evaluate toxicity associated with gastric radiation therapy.

EXPLORATORY OBJECTIVES:

  1. To determine if microbiome assessment can predict response to ultra-low dose radiation therapy and evaluate the differences in patient microbiome for patients who respond well and poorly to low dose radiation.

II. To determine if micro-ribonucleic acid (RNA) assessment can predict response to ultra-low dose radiation therapy and evaluate the differences in patient microRNA profiles for patients who respond well and poorly to low dose radiation.

III. To explore the role of magnetic resonance imaging (MRI) for staging gastric MALT lymphoma and for predicting response to ultra-low dose radiation therapy.

IV. To encourage optional co-enrollment on study PA18-0644 to facilitate collection and archiving of blood based biomarkers and microbiome samples for patients receiving ultra low dose radiation therapy.

OUTLINE:

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.

After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Being tested
Radiation Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation TherapyDrug

    Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated

    Undergo ultra low-dose radiation

Study groups in NCT03680586
Study groupRoleWhat they receive
Treatment (low-dose radiation therapy)ExperimentalPatients 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.
Receives: Drug: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete gastric response

    The complete response rate at one year will be estimated along with 95% confidence intervals.

    Measured: Up to 1 year

Secondary outcomes (6)

  1. Distant recurrence defined as disease progression outside of the stomach that was not present initially

    Distant recurrence rate at one year will be estimated along with 95% confidence intervals.

    Measured: Up to 1 year

  2. Incidence of acute gastrointestinal toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03

    Toxicity data will be summarized by frequency tables.

    Measured: Up to 1 year

  3. Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03

    Toxicity data will be summarized by frequency tables.

    Measured: Up to 1 year

  4. Time to local gastric event

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

  5. Time to distant event

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

  6. Tumor response

    The tumor responses will be summarized stratified by systemic treatments.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2018
  2. Study start4 Feb 2019
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03680586
Sponsor's protocol ID
2018-0392
Other IDs
NCI-2018-01948, 2018-0392
Status last verified
Oct 2026
First submitted
20 Sep 2018
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gunther JR, Xu J, Bhutani MS, Strati P, Fang PQ, Wu SY, Dabaja BS, Dong W, Bhosale PR, Flowers CR, Nair R, Malpica Castillo L, Fayad L, Iyer SP, Parmer S, Wang M, Lee HJ, Samaniego F, Westin J, Ahmed S, Nze CC, Jain P, Neelapu SS, Rodriguez MA, Chihara D, Nastoupil LJ, Pinnix CC. Response-adapted ultra-low-dose 4 Gy radiation as definitive therapy of gastric MALT lymphoma: a single-centre, pilot trial. Lancet Haematol. 2024 Jul;11(7):e521-e529. doi: 10.1016/S2352-3026(24)00133-9. Epub 2024 Jun 3.

    PubMed 38843856

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Radiation Therapy in people with Gastric Mucosa-Associated Lymphoid Tissue Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete gastric response (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03680586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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