isrt 20 gy for indolent localized gastrointestinal (gi)-lymphoma

Conditions: Follicular Lymphoma (Gastric or Duodenal); Marginal Zone Lymphoma (Gastric or Duodenal)

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)

* prove the effectiveness of 20 gy (and non-inferiority to actually recommended 30 gy) with respect to response rate 6 months after radiotherapy. * correlation of blood serum biomarker levels with lymphoma response to radiation treatment * recording of survival rates, quality of life (qol), radiogenic toxicities and inflammation relevant molecules in blood serum. primary objective: response rate 6 months after end of treatment, 4 categories according to gela-criteria: cr (complete remission) = cr or pmrd (probable minimal residual disease), pr (partial remission) = rrd (responding residual disease), nc (no change), pd (progressive disease) secondary objectives: qol according to eortc (qlq c30 and sto22). efs=event-free survival (time to any failure or death from any cause, patients in cr or pr), lss=lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients), pfs=progression-free survival (time to progression of lymphoma or death from any cause, all patients), os=overall survival (time to death from any cause, all patients). level of cytokines il-1β, il-4, il-8, tnfalpha and other inflammation relevant molecules syndecan1, mmp-2 and s100 proteins. acute toxicities during treatment according to nci-ctc, chronic toxicities according to nci-ctc/ lent-soma. monitoring of adverse events (aes) and serious adverse events (saes) -assessment of safety: monitoring of adverse events (aes) and serious adverse events (saes)

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

Keywords: lymphoma lymphoma, b-cell, marginal zone neoplasms by histologic type neoplasms lymphoproliferative disorders lymphatic diseases immunoproliferative disorders immune system diseases lymphoma, b-cell lymphoma, non-hodgkin lymphoma, follicular