Back to resultsISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
Primary Purpose
Follicular Lymphoma (Gastric or Duodenal), Marginal Zone Lymphoma (Gastric or Duodenal)
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma (Gastric or Duodenal) focused on measuring 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
Eligibility 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
Sites / Locations
- Department of Radiation OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (low-dose radiation therapy)
Arm Description
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)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
QoL #1
According to QLQ C30 (EORTC)
QoL #2
According to STO22 (EORTC)
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 in blood serum
IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins
Acute and chronic toxicities
Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA
Full Information
NCT ID
NCT04097067
First Posted
September 17, 2019
Last Updated
May 16, 2023
Sponsor
University Hospital Muenster
Collaborators
International Lymphoma Radiation Oncology Group (ILROG)
1. Study Identification
Unique Protocol Identification Number
NCT04097067
Brief Title
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster
Collaborators
International Lymphoma Radiation Oncology Group (ILROG)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma (Gastric or Duodenal), Marginal Zone Lymphoma (Gastric or Duodenal)
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (low-dose radiation therapy)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Low dose radiotherapy with 20 Gy (10x2Gy)
Primary Outcome Measure Information:
Title
Response rate
Description
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)
Time Frame
Until 6 months after end of treatment
Secondary Outcome Measure Information:
Title
QoL #1
Description
According to QLQ C30 (EORTC)
Time Frame
Until 6 months after end of treatment
Title
QoL #2
Description
According to STO22 (EORTC)
Time Frame
Until 6 months after end of treatment
Title
EFS
Description
Event-free survival (time to any failure or death from any cause, patients in CR or PR)
Time Frame
Until at least 6 months after end of treatment
Title
LSS
Description
Lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients)
Time Frame
Until at least 6 months after end of treatment
Title
PFS
Description
Progression-free survival (time to progression of lymphoma or death from any cause, all patients)
Time Frame
Until at least 6 months after end of treatment
Title
OS
Description
Overall survival (time to death from any cause, all patients)
Time Frame
Until at least 6 months after end of treatment
Title
Level of cytokines in blood serum
Description
IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins
Time Frame
Until 6 months after end of treatment
Title
Acute and chronic toxicities
Description
Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA
Time Frame
Until at least 6 months after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriele Reinartz, MD (Priv. Doz.)
Phone
+492518347358
Email
gabriele.reinartz@ukmuenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Fischer
Phone
+492518347358
Email
tina.fischer@ukmuenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. H. Th. Eich
Organizational Affiliation
Department of Radiation Oncology University Hospital Muenster
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Priv. Doz. Dr. G. Reinartz
Organizational Affiliation
Department of Radiation Oncology University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology
City
Münster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Reinartz, MD (Priv. Doz.)
Phone
+492518347358
Email
gabriele.reinartz@ukmuenster.de
First Name & Middle Initial & Last Name & Degree
Stephan Rehn, MD
Phone
+492518347358
Email
stephan.rehn@ukmuenster.de
12. IPD Sharing Statement
Learn more about this trial
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
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