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

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ClinicalTrials.gov Identifier: NCT03680586
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Gastric Mucosa-Associated Lymphoid Tissue Lymphoma Radiation: Radiation Therapy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Gastric MALT Lymphoma
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : May 8, 2021
Estimated Study Completion Date : May 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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.
Radiation: Radiation Therapy
Undergo ultra low-dose radiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation




Primary Outcome Measures :
  1. Complete gastric response [ Time Frame: Up to 1 year ]
    The complete response rate at one year will be estimated along with 95% confidence intervals.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Time to local gastric event [ Time Frame: Up to 1 year ]
    Will be estimated using the Kaplan-Meier method.

  5. Time to distant event [ Time Frame: Up to 1 year ]
    Will be estimated using the Kaplan-Meier method.

  6. Tumor response [ Time Frame: Up to 1 year ]
    The tumor responses will be summarized stratified by systemic treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  • Patients with compromised renal function or contrast allergies that prevent staging with contrast-enhanced computed tomography (CT)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680586


Contacts
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Contact: Jillian Gunther 713-563-2300 jgunther@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jillian Gunther    713-563-2300      
Principal Investigator: Jillian Gunther         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jillian Gunther M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03680586     History of Changes
Other Study ID Numbers: 2018-0392
NCI-2018-01948 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0392 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin