ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
Germany83 participantsStarted 2019-09-01
Plain-language summary
This trial studies the effectivity of low-dose radiation therapy with 10x2Gy for the treatment of patients with stage I-II stomach or duodenal Lymphoma (Marginal Zone or Follicular)
Who can participate
Age range
18 Years
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:
* primary indolent gastric or duodenal lymphoma
* pathology: marginal zone lymphoma (MZL) or follicular lymphoma (FL)
* stage: clinical stage I or II (Ann Arbor classification)
* H. pylori negative or antibiotic resistant lymphoma
* IPI or FLIPI score low - high (0-4)
* any size of tumor or affected lymph nodes
* male or female with age ≥ 18 years
* performance status ECOG 0 - 3
* written informed consent by the patient
Exclusion Criteria:
* prior radiation treatment of the gastrointestinal lymphoma
* stage: clinical stage III or IV (Ann Arbor classification)-unability to understand the informed consent or unwillingness to participate in the study
* severe comorbidity or organ dysfunction contraindicating the use of RT (liver cirrhosis Child-Pugh C, chronic obstructive pulmonary disease GOLD 4, heart insufficiency NYHA IV, dialysis dependent renal insufficiency, uncontrolled epilepsy)
* known seropositivity for HIV
* acute hepatitis B or C infection
* chronic inflammatory bowel disease
* prior malignant disease (exclusion: basalioma, non-metastasized solid tumor in constant remission diagnosed \>3 years ago)
* pregnancy or breastfeeding
* active substance abuse or severely compromised compliance
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.