search
Back to results

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

Primary Purpose

Gastric Mucosa-Associated Lymphoid Tissue Lymphoma

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Mucosa-Associated Lymphoid Tissue Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (low-dose radiation therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03
Toxicity data will be summarized by frequency tables.
Time to local gastric event
Will be estimated using the Kaplan-Meier method.
Time to distant event
Will be estimated using the Kaplan-Meier method.
Tumor response
The tumor responses will be summarized stratified by systemic treatments.

Full Information

First Posted
September 20, 2018
Last Updated
September 26, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03680586
Brief Title
Ultra Low-Dose Radiation Therapy in Treating Patients With Stage I-IV Stomach MALT Lymphoma
Official Title
Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Gastric MALT Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
PRIMARY OBJECTIVE: I. 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: I. To evaluate distant recurrence of marginal zone lymphoma at one year. II. To evaluate toxicity associated with gastric radiation therapy. EXPLORATORY OBJECTIVES: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Mucosa-Associated Lymphoid Tissue Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (low-dose radiation therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo ultra low-dose radiation
Primary Outcome Measure Information:
Title
Complete gastric response
Description
The complete response rate at one year will be estimated along with 95% confidence intervals.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Distant recurrence defined as disease progression outside of the stomach that was not present initially
Description
Distant recurrence rate at one year will be estimated along with 95% confidence intervals.
Time Frame
Up to 1 year
Title
Incidence of acute gastrointestinal toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Description
Toxicity data will be summarized by frequency tables.
Time Frame
Up to 1 year
Title
Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03
Description
Toxicity data will be summarized by frequency tables.
Time Frame
Up to 1 year
Title
Time to local gastric event
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
Up to 1 year
Title
Time to distant event
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
Up to 1 year
Title
Tumor response
Description
The tumor responses will be summarized stratified by systemic treatments.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jillian Gunther
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs