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

August 26, 2024 updated by: University Hospital Muenster

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Until 6 months after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL #1
Time Frame: Until 6 months after end of treatment
According to QLQ C30 (EORTC)
Until 6 months after end of treatment
QoL #2
Time Frame: Until 6 months after end of treatment
According to STO22 (EORTC)
Until 6 months after end of treatment
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)
Until at least 6 months after end of treatment
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)
Until at least 6 months after end of treatment
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)
Until at least 6 months after end of treatment
OS
Time Frame: Until at least 6 months after end of treatment
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
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
Until 6 months after end of treatment
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
Until at least 6 months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

International Lymphoma Radiation Oncology Group (ILROG)

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKM01_2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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