ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
NCT ID: NCT04097067
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
83 participants
INTERVENTIONAL
2019-09-01
2025-08-31
Brief Summary
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Detailed Description
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* 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)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (low-dose radiation therapy)
Patients undergo low-dose radiation therapy with daily 2 Gy ad 20 Gy (ISRT with IMRT \& IGRT).
Blood draw for biomarker-analysis (at baseline visit/ after 4 Gy/ after 10 Gy / after 20 Gy RT/ at 3 and 6 months after RT)
Radiation Therapy
Low dose radiotherapy with 20 Gy (10x2Gy)
Interventions
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Radiation Therapy
Low dose radiotherapy with 20 Gy (10x2Gy)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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International Lymphoma Radiation Oncology Group (ILROG)
UNKNOWN
University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Prof. Dr. H. Th. Eich
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology University Hospital Muenster
Priv. Doz. Dr. G. Reinartz
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology University Hospital Muenster
Locations
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Department of Radiation Oncology
Münster, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UKM01_2019
Identifier Type: -
Identifier Source: org_study_id
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