Clinical trial · Interventional
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
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
NCT04097067CI-TRIAL-00080239unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma (Gastric or Duodenal) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Marginal Zone Lymphoma (Gastric or Duodenal) | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (low-dose radiation therapy)
- 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)
- interventionNames
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Until 6 months after end of treatment
- 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)
Secondary outcomes (8)
- measure
- QoL #1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.