Gastric Mucosa-Associated Lymphoid Tissue Lymphoma Clinical Trial
Official title:
Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Gastric MALT Lymphoma
| Verified date | April 2024 |
| Source | M.D. Anderson Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 25 |
| Est. completion date | April 30, 2025 |
| Est. primary completion date | April 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | M D Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete gastric response | The complete response rate at one year will be estimated along with 95% confidence intervals. | Up to 1 year | |
| Secondary | 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. | Up to 1 year | |
| Secondary | 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. | Up to 1 year | |
| Secondary | Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03 | Toxicity data will be summarized by frequency tables. | Up to 1 year | |
| Secondary | Time to local gastric event | Will be estimated using the Kaplan-Meier method. | Up to 1 year | |
| Secondary | Time to distant event | Will be estimated using the Kaplan-Meier method. | Up to 1 year | |
| Secondary | Tumor response | The tumor responses will be summarized stratified by systemic treatments. | Up to 1 year |