Lymphoma Lymphoma
Conditions
Interventions
Involved Site RadioTherapy (ISRT) with 20 Gy
ISRT 20 Gy
Sponsors
Taguchi Senzo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. primary indolent gastric or duodenal lymphoma 2. pathology: marginal zone lymphoma (MZL) or follicular lymphoma (FL) 3. stage: clinical stage I or II (Ann Arbor classification) 4. H. pylori negative or antibiotic resistant lymphoma 5. any FLIPI score low - high (0 - 4) 6. any size of tumor or affected lymph nodes 7. male or female with age 18 years or older 8. performance status ECOG 0 - 3 9. written informed consent by the patient
Exclusion criteria
Exclusion criteria: 1. prior radiation treatment of the gastrointestinal lymphoma 2. stage: clinical stage III or IV (Ann Arbor classification)-unability to understand the informed consent or un willingness to participate in the study 3. 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) 4. known seropositivity for HIV 5. acute hepatitis B or C infection 6. chronic inflammatory bowel disease 7. prior malignant disease (exclusion: basalioma, non- metastasized solid tumor in constant remission diagnosed >3 years ago) 8. pregnancy or breastfeeding 9. active substance abuse or severely compromised compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate 6 months after end of treatment, 4 categories according to GELA-criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL according to EORTC (QLQ C30 and STO22). EFS=Event- free survival (time to any failure or death from any cause, all patients), PFS=Progression-free survival (time to progression of lymphoma or death from any cause, patients in PR or SD), RFS=Recurrence-free survival (time to recurrence of lymphoma or death from any cause, patients in CR), LSS=Lymphoma- specific survival (time to death related to lymphoma or associated with the treatment, all patients), OS=Overall survival(time to death from any cause, all patients). Level of cytokines IL-1beta, 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) | — |
Countries
Canada, China, Germany, Italy, Japan, Singapore, USA
Contacts
Public ContactSenzo Taguchi
Cancer Institute Hospital Japanese Foundation for Cancer Research
Outcome results
None listed