Follicular Lymphoma (Gastric or Duodenal)NCT04097067
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
A study testing Radiation Therapy in people with Follicular Lymphoma (Gastric or Duodenal) and Marginal Zone Lymphoma (Gastric or Duodenal), run by University Hospital Muenster at 1 site in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma (Gastric or Duodenal), Marginal Zone Lymphoma (Gastric or Duodenal)
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- male or female with age ≥ 18 years
- performance status ECOG 0 - 3
- written informed consent by the patient
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology
Münster, North Rhine-Westphalia, 48149
Gabriele Reinartz, MD (Priv. Doz.), +492518347358, gabriele.reinartz@ukmuenster.de
Stephan Rehn, MD, +492518347358, stephan.rehn@ukmuenster.de
About this study
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
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)
Read the 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)
- Being tested
- Radiation Therapy
- 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
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Low dose radiotherapy with 20 Gy (10x2Gy)
| Study group | Role | What they receive |
|---|---|---|
| Treatment (low-dose radiation therapy) | Experimental | 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) Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Until 6 months after end of treatment
Secondary outcomes (8)
QoL #1
According to QLQ C30 (EORTC)
Measured: Until 6 months after end of treatment
QoL #2
According to STO22 (EORTC)
Measured: Until 6 months after end of treatment
EFS
Event-free survival (time to any failure or death from any cause, patients in CR or PR)
Measured: Until at least 6 months after end of treatment
LSS
Lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients)
Measured: Until at least 6 months after end of treatment
PFS
Progression-free survival (time to progression of lymphoma or death from any cause, all patients)
Measured: Until at least 6 months after end of treatment
OS
Overall survival (time to death from any cause, all patients)
Measured: Until at least 6 months after end of treatment
Level of cytokines in blood serum
IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins
Measured: Until 6 months after end of treatment
Acute and chronic toxicities
Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA
Measured: Until at least 6 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Sep 2019
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Lymphoma (Gastric or Duodenal)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- International Lymphoma Radiation Oncology Group (ILROG)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. H. Th. Eich, Principal investigator, Department of Radiation Oncology University Hospital MuensterPriv. Doz. Dr. G. Reinartz, Principal investigator, Department of Radiation Oncology University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097067
- Sponsor's protocol ID
- UKM01_2019
- Status last verified
- Aug 2024
- First submitted
- 17 Sep 2019
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04097067
- Acronym / sponsor ID
- UKM01_2019
- Keywords
- Lymphoma, Lymphoma, B-Cell, Marginal Zone, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- International Lymphoma Radiation Oncology Group (ILROG)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (low-dose radiation therapy) | Experimental | Radiation: Radiation TherapyPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyLow dose radiotherapy with 20 Gy (10x2Gy) | Radiation | Treatment (low-dose radiation therapy) |
Primary outcome
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)
8 secondary outcomes
QoL #1
Time frame: Until 6 months after end of treatment
QoL #2
Time frame: Until 6 months after end of treatment
EFS
Time frame: Until at least 6 months after end of treatment
LSS
Time frame: Until at least 6 months after end of treatment
PFS
Time frame: Until at least 6 months after end of treatment
OS
Time frame: Until at least 6 months after end of treatment
Level of cytokines in blood serum
Time frame: Until 6 months after end of treatment
Acute and chronic toxicities
Time frame: Until at least 6 months after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy in people with Follicular Lymphoma (Gastric or Duodenal) and Marginal Zone Lymphoma (Gastric or Duodenal), run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Reinartz, MD (Priv. Doz.) (+492518347358, gabriele.reinartz@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Until 6 months after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.