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

Last updated: August 26, 2024
Sponsor: University Hospital Muenster
Overall Status: Active - Recruiting

Phase

N/A

Condition

Follicular Lymphoma

Lymphoma

Lymphoma, B-cell

Treatment

Radiation Therapy

Clinical Study ID

NCT04097067
UKM01_2019
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • prior radiation treatment of the gastrointestinal lymphoma

  • stage: clinical stage III or IV (Ann Arbor classification)-unability to understandthe informed consent or unwillingness to participate in the study

  • severe comorbidity or organ dysfunction contraindicating the use of RT (livercirrhosis Child-Pugh C, chronic obstructive pulmonary disease GOLD 4, heartinsufficiency NYHA IV, dialysis dependent renal insufficiency, uncontrolledepilepsy)

  • known seropositivity for HIV

  • acute hepatitis B or C infection

  • chronic inflammatory bowel disease

  • prior malignant disease (exclusion: basalioma, non-metastasized solid tumor inconstant remission diagnosed >3 years ago)

  • pregnancy or breastfeeding

  • active substance abuse or severely compromised compliance

Study Design

Total Participants: 83
Treatment Group(s): 1
Primary Treatment: Radiation Therapy
Phase:
Study Start date:
September 01, 2019
Estimated Completion Date:
August 31, 2025

Study 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)

Connect with a study center

  • Department of Radiation Oncology

    Münster, North Rhine-Westphalia 48149
    Germany

    Active - Recruiting

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