Follicular Lymphoma (Gastric or Duodenal) Clinical Trial
Official title:
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 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)
| Status | Recruiting |
| Enrollment | 83 |
| Est. completion date | August 31, 2025 |
| Est. primary completion date | August 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Radiation Oncology | Münster | North Rhine-Westphalia |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Muenster | International Lymphoma Radiation Oncology Group (ILROG) |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | Until 6 months after end of treatment | |
| Secondary | QoL #1 | According to QLQ C30 (EORTC) | Until 6 months after end of treatment | |
| Secondary | QoL #2 | According to STO22 (EORTC) | Until 6 months after end of treatment | |
| Secondary | EFS | Event-free survival (time to any failure or death from any cause, patients in CR or PR) | Until at least 6 months after end of treatment | |
| Secondary | LSS | Lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients) | Until at least 6 months after end of treatment | |
| Secondary | PFS | Progression-free survival (time to progression of lymphoma or death from any cause, all patients) | Until at least 6 months after end of treatment | |
| Secondary | OS | Overall survival (time to death from any cause, all patients) | Until at least 6 months after end of treatment | |
| Secondary | Level of cytokines in blood serum | IL-1ß, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins | Until 6 months after end of treatment | |
| Secondary | Acute and chronic toxicities | Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA | Until at least 6 months after end of treatment |