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New treatment option for Follicular Lymphoma (Gastric or Duodenal)
Official title ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
ClinicalTrials.gov ID: NCT04097067
What this study is testing
- What it's testing
- 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)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- known seropositivity for HIV
- acute hepatitis B or C infection
- chronic inflammatory bowel disease
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Münster, North Rhine-Westphalia, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Münster, North Rhine-Westphalia, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.