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
Conditions
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.
Interventions
OTHERRadiation Therapy
Undergo radiation therapy
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
75 participants enrolled in study, 2 participants did not receive Radiation Therapy(RT); 1 owing to discovered stage III disease and 1 who chose observation after complete surgical resection of disease in a gastric polyp.
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Radiation Therapy) Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
Radiation Therapy: Undergo radiation therapy | 73 |
| Total | 73 |
Baseline characteristics
| Characteristic | Treatment (Radiation Therapy) | — |
|---|---|---|
| Age, Continuous | 57 years | — |
| Clinical Stage I | 61 Participants | — |
| Clinical Stage II | 10 Participants | — |
| Clinical Stage IV | 2 Participants | — |
| Helicobacter pylori positive at initial diagnosis | 13 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Radiation dose, Gy 24-28.5 | 8 Participants | — |
| Radiation dose, Gy 30-30.6 | 45 Participants | — |
| Radiation dose, Gy 33-39.6 | 20 Participants | — |
| Region of Enrollment United States | 73 participants | — |
| Sex: Female, Male Female | 38 Participants | — |
| Sex: Female, Male Male | 35 Participants | — |
| Treatment before radiation therapy Antibiotics | 22 Participants | — |
| Treatment before radiation therapy None | 27 Participants | — |
| Treatment before radiation therapy Other | 1 Participants | — |
| Treatment before radiation therapy Rituximab | 3 Participants | — |
| Treatment before radiation therapy Surgery | 19 Participants | — |
| Treatment before radiation therapy Unknown | 1 Participants | — |
| Tumor Location Head and neck (nonorbit) | 13 Participants | — |
| Tumor Location Orbit | 17 Participants | — |
| Tumor Location Other | 5 Participants | — |
| Tumor Location Skin | 4 Participants | — |
| Tumor Location Stomach | 34 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 73 |
| other Total, other adverse events | 28 / 73 |
| serious Total, serious adverse events | 0 / 73 |
Outcome results
Primary
Relapse-free Survival (RFS)
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.
Time frame: Through study completion, up to 10 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Radiation Therapy) | Relapse-free Survival (RFS) | 83 months |
Secondary
10 Year Overall Survival (OS)
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.
Time frame: Through study completion, up to 10 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Radiation Therapy) | 10 Year Overall Survival (OS) | 86 months |
Secondary
Median Progression Free Survival (PFS)
PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.
Time frame: 17.5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Radiation Therapy) | Median Progression Free Survival (PFS) | 17.5 months |
Secondary
Progression Free Survival (PFS) at 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.
Time frame: Through study completion, up to 10 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Radiation Therapy) | Progression Free Survival (PFS) at 10 Years | 73 months |