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
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Department of Radiation Oncology
RECRUITING
Münster
Contact Information
Primary
Gabriele Reinartz, MD (Priv. Doz.)
gabriele.reinartz@ukmuenster.de
+492518347358
Backup
Tina Fischer
tina.fischer@ukmuenster.de
+492518347358
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 83
Treatments
Experimental: Treatment (low-dose radiation therapy)
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)
Authors
Dr. G. Reinartz
Related Therapeutic Areas
Sponsors
Collaborators: International Lymphoma Radiation Oncology Group (ILROG)
Leads: University Hospital Muenster