ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
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)
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04097067.
Locations matching your search criteria
United States
Massachusetts
Boston
- 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)
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity Hospital Muenster
- Primary IDUKM01_2019
- Secondary IDsNCI-2022-05852
- ClinicalTrials.gov IDNCT04097067