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| Name | Class |
|---|---|
| International Lymphoma Radiation Oncology Group (ILROG) | UNKNOWN |
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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)
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (low-dose radiation therapy) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Low dose radiotherapy with 20 Gy (10x2Gy) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriele Reinartz, MD (Priv. Doz.) | Contact | +492518347358 | gabriele.reinartz@ukmuenster.de | |
| Tina Fischer | Contact | +492518347358 | tina.fischer@ukmuenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. H. Th. Eich | Department of Radiation Oncology University Hospital Muenster | Principal Investigator |
| Priv. Doz. Dr. G. Reinartz | Department of Radiation Oncology University Hospital Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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 |