Status:
RECRUITING
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
International Lymphoma Radiation Oncology Group (ILROG)
Conditions:
Follicular Lymphoma (Gastric or Duodenal)
Marginal Zone Lymphoma (Gastric or Duodenal)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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)
Detailed Description
* 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 lym...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04097067
Start Date
September 1 2019
End Date
August 31 2025
Last Update
August 27 2024
Active Locations (1)
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1
Department of Radiation Oncology
Münster, North Rhine-Westphalia, Germany, 48149