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

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ClinicalTrials.gov Identifier: NCT04097067
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
International Lymphoma Radiation Oncology Group (ILROG)
Information provided by (Responsible Party):
University Hospital Muenster

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
Follicular Lymphoma (Gastric or Duodenal) Marginal Zone Lymphoma (Gastric or Duodenal) Radiation: Radiation Therapy Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial to Assess the Efficacy of Low Radiation Dose of 20 Gy for the Treatment of Marginal Zone Lymphoma or Follicular Lymphoma Stage I-II Localized in the Stomach or the Duodenum
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021


Arm Intervention/treatment
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)




Primary Outcome Measures :
  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 Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097067


Contacts
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Contact: Gabriele Reinartz, MD +492518347358 gabriele.reinartz@ukmuenster.de
Contact: Sandra Lammers +492518347358 Study.Radiooncology@ukmuenster.de

Locations
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Germany
Department of Radiation Oncology Recruiting
Münster, North Rhine-Westphalia, Germany, 48149
Contact: Gabriele Reinartz, MD    +492518347358    gabriele.reinartz@ukmuenster.de   
Contact: Stephan Rehn, MD    +492518347358    stephan.rehn@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
International Lymphoma Radiation Oncology Group (ILROG)
Investigators
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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

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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04097067     History of Changes
Other Study ID Numbers: UKM01_2019
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell