Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MAL… (NCT04465162) | Clinical Trial Compass
CompletedPhase 2
Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
United States75 participantsStarted 2000-06-07
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relapse-free Survival (RFS)
Timeframe: Through study completion, up to 10 years