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

Phase 2

Completed

• Conditions: Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Extranodal Marginal Zone Lymphoma
• Interventions: Other: Radiation Therapy

• Registration Number: NCT04465162
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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 Timeline

• Study Start: 2000-06-07
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-09
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15
• Results First Submitted: 2022-01-05
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-25
• Last Update Submitted: 2022-02-25
• Results First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (radiation therapy)	Radiation Therapy	Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.

Primary Outcome Measures

Name	Time	Method
Relapse-free Survival (RFS)	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

Name	Time	Method
10 Year Overall Survival (OS)	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.
Median Progression Free Survival (PFS)	17.5 years	PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.
Progression Free Survival (PFS) at 10 Years	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States