- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03680586
Ultra Low-Dose Radiation Therapy in Treating Patients With Stage I-IV Stomach MALT Lymphoma
Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Gastric MALT Lymphoma
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Jillian Gunther, MD
- Phone Number: 713-563-2300
- Email: jgunther@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (low-dose radiation therapy)
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.
|
Undergo ultra low-dose radiation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete gastric response
Time Frame: Up to 1 year
|
The complete response rate at one year will be estimated along with 95% confidence intervals.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distant recurrence defined as disease progression outside of the stomach that was not present initially
Time Frame: Up to 1 year
|
Distant recurrence rate at one year will be estimated along with 95% confidence intervals.
|
Up to 1 year
|
Incidence of acute gastrointestinal toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Time Frame: Up to 1 year
|
Toxicity data will be summarized by frequency tables.
|
Up to 1 year
|
Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03
Time Frame: Up to 1 year
|
Toxicity data will be summarized by frequency tables.
|
Up to 1 year
|
Time to local gastric event
Time Frame: Up to 1 year
|
Will be estimated using the Kaplan-Meier method.
|
Up to 1 year
|
Time to distant event
Time Frame: Up to 1 year
|
Will be estimated using the Kaplan-Meier method.
|
Up to 1 year
|
Tumor response
Time Frame: Up to 1 year
|
The tumor responses will be summarized stratified by systemic treatments.
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jillian Gunther, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0392 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01948 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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