Low-dose radiation therapy for localized gastrointestinal 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
This study tests if a lower dose of radiation therapy can effectively treat early-stage gastric or duodenal lymphoma, helping patients feel better without the higher dose's side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 83 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Muenster Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Münster, North Rhine-Westphalia) |
| Trial ID | NCT04097067 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of low-dose radiation therapy (20 Gy) for patients with stage I-II gastric or duodenal lymphoma, specifically targeting marginal zone and follicular lymphoma. The study aims to demonstrate that this lower dose is non-inferior to the standard 30 Gy in terms of response rates six months post-treatment. Additionally, it will assess correlations between blood serum biomarkers and treatment response, while monitoring survival rates, quality of life, and potential toxicities associated with the therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with primary indolent gastric or duodenal lymphoma at clinical stage I or II.
Not a fit: Patients with advanced stage III or IV lymphoma or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less intensive treatment option with fewer side effects for patients with localized gastrointestinal lymphoma.
How similar studies have performed: Other studies have shown promising results with low-dose radiation therapy for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Münster, North Rhine-Westphalia
- Department of Radiation Oncology — Münster, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Prof. Dr. H. Th. Eich — Department of Radiation Oncology University Hospital Muenster
- Study coordinator: Gabriele Reinartz, MD (Priv. Doz.)
- Email: gabriele.reinartz@ukmuenster.de
- Phone: +492518347358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.