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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Low dose radiotherapy with 20 Gy (10x2Gy)
Department of Radiation Oncology
Münster, North Rhine-Westphalia, Germany
RECRUITINGResponse rate
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)
Time frame: Until 6 months after end of treatment
QoL #1
According to QLQ C30 (EORTC)
Time frame: Until 6 months after end of treatment
QoL #2
According to STO22 (EORTC)
Time frame: Until 6 months after end of treatment
EFS
Event-free survival (time to any failure or death from any cause, patients in CR or PR)
Time frame: Until at least 6 months after end of treatment
LSS
Lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients)
Time frame: Until at least 6 months after end of treatment
PFS
Progression-free survival (time to progression of lymphoma or death from any cause, all patients)
Time frame: Until at least 6 months after end of treatment
OS
Overall survival (time to death from any cause, all patients)
Time frame: Until at least 6 months after end of treatment
Level of cytokines in blood serum
IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins
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Time frame: Until 6 months after end of treatment
Acute and chronic toxicities
Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA
Time frame: Until at least 6 months after end of treatment