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

Study Overview
=================
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 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)

Official Title
-----------------
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

Conditions
-----------------
Follicular Lymphoma (Gastric or Duodenal), Marginal Zone Lymphoma (Gastric or Duodenal)

Intervention / Treatment
-----------------
* Radiation: Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (low-dose radiation therapy)<br>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: Radiation Therapy<br>* Low dose radiotherapy with 20 Gy (10x2Gy)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response 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) | Until 6 months after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL #1 | According to QLQ C30 (EORTC) | Until 6 months after end of treatment | 
| QoL #2 | According to STO22 (EORTC) | 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) | 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) | 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) | Until at least 6 months after end of treatment | 
| OS | Overall survival (time to death from any cause, all patients) | 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 | 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 | Until at least 6 months after end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Lymphoma, B-Cell, Marginal Zone, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, follicular