NCT04097067

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

6 years

First QC Date

September 17, 2019

Last Update Submit

August 26, 2024

Conditions

Follicular Lymphoma (Gastric or Duodenal)Marginal Zone Lymphoma (Gastric or Duodenal)

Keywords

LymphomaLymphoma, B-Cell, Marginal ZoneNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinLymphoma, follicular

Outcome Measures

Primary Outcomes (1)

  • 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)

    Until 6 months after end of treatment

Secondary Outcomes (8)

  • QoL #1

    Until 6 months after end of treatment

  • QoL #2

    Until 6 months after end of treatment

  • EFS

    Until at least 6 months after end of treatment

  • LSS

    Until at least 6 months after end of treatment

  • PFS

    Until at least 6 months after end of treatment

  • +3 more secondary outcomes

Study Arms (1)

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)

Radiation: Radiation Therapy

Interventions

Radiation TherapyRADIATION

Low dose radiotherapy with 20 Gy (10x2Gy)

Treatment (low-dose radiation therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • pregnancy or breastfeeding
  • active substance abuse or severely compromised compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Reinartz, MD (Priv. Doz.)

CONTACT

+492518347358gabriele.reinartz@ukmuenster.de

Tina Fischer

CONTACT

+492518347358tina.fischer@ukmuenster.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 20, 2019

Study Start

September 1, 2019

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

DE(1)