JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04097067

Studienbeginn:
September 2019

Letztes Update:
17.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Muenster

Collaborator:
International Lymphoma Radiation Oncology Group (ILROG)

Studienleiter

Prof. Dr. H. Th. Eich
Principal Investigator
Department of Radiation Oncology University Hospital Muenster

Priv. Doz. Dr. G. Reinartz
Principal Investigator
Department of Radiation Oncology University Hospital Muenster

Kontakt

Gabriele Reinartz, MD (Priv. Doz.)
Kontakt:
Phone: +492518347358
E-Mail: gabriele.reinartz@ukmuenster.de» Kontaktdaten anzeigen

Tina Fischer
Kontakt:
Phone: +492518347358
E-Mail: tina.fischer@ukmuenster.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Radiation Oncology
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Gabriele Reinartz, MD (Priv. Doz.)
Phone: +492518347358
E-Mail: gabriele.reinartz@ukmuenster.de

Stephan Rehn, MD
Phone: +492518347358
E-Mail: stephan.rehn@ukmuenster.de» Ansprechpartner anzeigen

Studien-Informationen

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)

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Response rate (Time Frame - 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:

1. QoL #1 (Time Frame - Until 6 months after end of treatment):
According to QLQ C30 (EORTC)

2. QoL #2 (Time Frame - Until 6 months after end of treatment):
According to STO22 (EORTC)

3. EFS (Time Frame - 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)

4. LSS (Time Frame - 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)

5. PFS (Time Frame - Until at least 6 months after end of treatment):
Progression-free survival (time to progression of lymphoma or death from any cause, all patients)

6. OS (Time Frame - Until at least 6 months after end of treatment):
Overall survival (time to death from any cause, all patients)

7. Level of cytokines in blood serum (Time Frame - 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

8. Acute and chronic toxicities (Time Frame - 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

Geprüfte Regime

Radiation Therapy:
Low dose radiotherapy with 20 Gy (10x2Gy)

Quelle: ClinicalTrials.gov

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