ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Muenster
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Radiation Therapy
RadiationLow dose radiotherapy with 20 Gy (10x2Gy)
Treatment groups
83 Participants
are divided into 1 treatment groupGroup A: Treatment (low-dose radiation therapy)Experimental treatment 1 intervention
Trial outcomes
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)
Time frame
Until 6 months after end of treatmentSecondary outcomes
1
QoL #1
According to QLQ C30 (EORTC)
Time frame
Until 6 months after end of treatment2
QoL #2
According to STO22 (EORTC)
Time frame
Until 6 months after end of treatment3
EFS
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 treatment4
LSS
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 treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Muenster
Lead sponsor
International Lymphoma Radiation Oncology Group (ILROG)
Collaborator
Source ClinicalTrials.gov