Follicular Lymphoma (Gastric or Duodenal), Marginal Zone Lymphoma (Gastric or Duodenal)
Conditions
Keywords
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
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)
Interventions
RADIATIONRadiation Therapy
Low dose radiotherapy with 20 Gy (10x2Gy)
Sponsors
International Lymphoma Radiation Oncology Group (ILROG)
University Hospital Muenster
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Until 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
| Measure | Time frame | Description |
|---|---|---|
| QoL #2 | Until 6 months after end of treatment | According to STO22 (EORTC) |
| EFS | Until at least 6 months after end of treatment | Event-free survival (time to any failure or death from any cause, patients in CR or PR) |
| LSS | Until at least 6 months after end of treatment | Lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients) |
| QoL #1 | Until 6 months after end of treatment | According to QLQ C30 (EORTC) |
| OS | Until at least 6 months after end of treatment | Overall survival (time to death from any cause, all patients) |
| Level of cytokines in blood serum | Until 6 months after end of treatment | IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins |
| Acute and chronic toxicities | Until at least 6 months after end of treatment | Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA |
| PFS | Until at least 6 months after end of treatment | Progression-free survival (time to progression of lymphoma or death from any cause, all patients) |
Countries
Germany
Contacts
Primary ContactGabriele Reinartz, MD (Priv. Doz.)
Backup ContactTina Fischer
Outcome results
None listed