Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT04097067
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04097067
Study Brief:
Protocol Section:
NCT04097067