ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
Study Details
Study Description
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)
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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Prove the effectiveness of 20 Gy (and non-inferiority to actually recommended 30 Gy) with respect to response rate 6 months after radiotherapy.
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Correlation of blood serum biomarker levels with lymphoma response to radiation treatment
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Treatment (low-dose radiation therapy) 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
Low dose radiotherapy with 20 Gy (10x2Gy)
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- QoL #1 [Until 6 months after end of treatment]
According to QLQ C30 (EORTC)
- 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)
- 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)
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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primary indolent gastric or duodenal lymphoma
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pathology: marginal zone lymphoma (MZL) or follicular lymphoma (FL)
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stage: clinical stage I or II (Ann Arbor classification)
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- pylori negative or antibiotic resistant lymphoma
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IPI or FLIPI score low - high (0-4)
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any size of tumor or affected lymph nodes
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male or female with age ≥ 18 years
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performance status ECOG 0 - 3
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written informed consent by the patient
Exclusion Criteria:
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prior radiation treatment of the gastrointestinal lymphoma
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stage: clinical stage III or IV (Ann Arbor classification)-unability to understand the informed consent or unwillingness to participate in the study
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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)
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known seropositivity for HIV
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acute hepatitis B or C infection
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chronic inflammatory bowel disease
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prior malignant disease (exclusion: basalioma, non-metastasized solid tumor in constant remission diagnosed >3 years ago)
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pregnancy or breastfeeding
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active substance abuse or severely compromised compliance
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Department of Radiation Oncology | Münster | North Rhine-Westphalia | Germany | 48149 |
Sponsors and Collaborators
- University Hospital Muenster
- International Lymphoma Radiation Oncology Group (ILROG)
Investigators
- Principal Investigator: Prof. Dr. H. Th. Eich, Department of Radiation Oncology University Hospital Muenster
- Principal Investigator: Dr. G. Reinartz, Department of Radiation Oncology University Hospital Muenster
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UKM01_2019