ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma

Phase 2

Recruiting

• Conditions: ymphoma; Lymphoma

• Registration Number: JPRN-jRCT1032210064
• Lead Sponsor: Taguchi Senzo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

1. primary indolent gastric or duodenal lymphoma
2. pathology: marginal zone lymphoma (MZL) or follicular lymphoma (FL)
3. stage: clinical stage I or II (Ann Arbor classification)
4. H. pylori negative or antibiotic resistant lymphoma
5. any FLIPI score low - high (0 - 4)
6. any size of tumor or affected lymph nodes
7. male or female with age 18 years or older
8. performance status ECOG 0 - 3
9. written informed consent by the patient

Exclusion Criteria

1. prior radiation treatment of the gastrointestinal lymphoma
2. stage: clinical stage III or IV (Ann Arbor classification)-unability to understand the informed consent or un willingness to participate in the study
3. 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)
4. known seropositivity for HIV
5. acute hepatitis B or C infection
6. chronic inflammatory bowel disease
7. prior malignant disease (exclusion: basalioma, non- metastasized solid tumor in constant remission diagnosed >3 years ago)
8. pregnancy or breastfeeding
9. active substance abuse or severely compromised compliance

Study & Design

• Study Type: Interventional
• Study Design: Not specified