Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoproliferative Disorders

Lymphoma, B-Cell

Neoplasms by Histologic Type

Immunoproliferative Disorders

Lymphatic Diseases

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

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)

Low dose radiotherapy with 20 Gy (10x2Gy)

Radiation Therapy

Gabriele Reinartz, MD (Priv. Doz.)

Tina Fischer

Stephan Rehn, MD

Prof. Dr. H. Th. Eich

Priv. Doz. Dr. G. Reinartz

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)

ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma

Phase II Trial to Assess the Efficacy of Low Radiation Dose of 20 Gy for the Treatment of Marginal Zone Lymphoma or Follicular Lymphoma Stage I-II Localized in the Stomach or the Duodenum

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)

Event-free survival (time to any failure or death from any cause, patients in CR or PR)

Lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients)

Progression-free survival (time to progression of lymphoma or death from any cause, all patients)

Overall survival (time to death from any cause, all patients)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma	NCT04097067	Follicular Lymp... Marginal Zone L...	Radiation Thera...	18 Years -	University Hospital Muenster
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma	NCT04097067	Follicular Lymp... Marginal Zone L...	Radiation Thera...	18 Years -	University Hospital Muenster
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma	NCT04097067	Follicular Lymp... Marginal Zone L...	Radiation Thera...	18 Years -	University Hospital Muenster

Spots Global Cancer Trial Database for marginal zone lymphoma (gastric or duodenal)