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Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465162
Recruitment Status : Completed
First Posted : July 9, 2020
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This trial studies the side effects of radiation therapy used alone, and if it can achieve a high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors. This treatment may improve the patient's lymphoma.

Condition or disease Intervention/treatment Phase
Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Extranodal Marginal Zone Lymphoma Other: Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To determine the efficacy and toxicity of radiation therapy alone in treating stage 1 and 2 MALT lymphoma for newly diagnosed patients and for the patients who failed other treatment modalities.

OUTLINE:

Patients undergo radiation therapy once daily (QD) 5 times weekly over 3.5-5 weeks.

After completion of study treatment, patients are followed up at 6-8 weeks, and then every 3-4 months for year 1, every 4-6 months for year 2, every 6 months for years 3 and 4, and once yearly thereafter.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiation Therapy Alone for Stage 1 and 2 MALT (Mucosa-Associated Lymphoid Tissue) Lymphoma
Actual Study Start Date : June 7, 2000
Actual Primary Completion Date : March 15, 2021
Actual Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (radiation therapy)
Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
 Other: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation


Outcome Measures
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Primary Outcome Measures :
  1. Relapse-free Survival (RFS) [ Time Frame: Through study completion, up to 10 years ]
    RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions.


Secondary Outcome Measures :
  1. Median Progression Free Survival (PFS) [ Time Frame: 17.5 years ]
    PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.

  2. Progression Free Survival (PFS) at 10 Years [ Time Frame: Through study completion, up to 10 years ]
    PFS events is the time in months and defined as any lymphoma relapse ( lymphoma that comes back after successful treatment and a period of remission) or death from any cause. Kaplan-Meier curves were estimated for the survival distributions.

  3. 10 Year Overall Survival (OS) [ Time Frame: Through study completion, up to 10 years ]
    Overall Survival is the time in months from start of study treatment to date of death due to any cause. Overall survival rates are estimated by the Kaplan-Meier method.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed stage 1 and 2 MALT lymphoma are eligible for this study
  • Patients with Helicobacter (H.) pylori positive gastric MALT lymphoma are recommended to have treatments with antibiotics prior to enrollment to this protocol
  • Patients who failed other treatment modalities (e.g. chemotherapy, antibiotics therapy etc) are also eligible as far as they never had stage 3 or 4 disease during the course of the disease or disease progression to the opposite side of the diaphragm (as the time course of the response to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic treatment will be defined as no response or progression of the disease documented by endoscopy and biopsy)
  • Patients who have had stage 4 diseases due to bilateral parotid gland or ocular/ocular adnexal involvement or due to multiple sites within Waldeyer's ring will still be eligible

Exclusion Criteria:

  • Patients who had previous radiation dose to the site of the current primary disease which would lead to violation of known radiation tolerance limit of that particular site if treated again
  • Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm will be ineligible
  • Previous or concurrent malignancy in any form would not be an exclusion criterion. However, patients who receive chemotherapy for concurrent malignancy will be excluded from statistical analysis
  • Low blood cell counts would not be exclusion criteria as far as the patient is willing to accept supportive measures such as transfusions, filgrastim and epoetin
Contacts and Locations
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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): NCT04465162


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bouthaina S Dabaja M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] August 11, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04465162    
Other Study ID Numbers: ID99-384
NCI-2020-02549 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ID99-384 ( Other Identifier: M D Anderson Cancer Center )
First Posted: July 9, 2020    Key Record Dates
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
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