Clinical trial NCT04097067: ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Follicular Lymphoma (Gastric or Duodenal)
Marginal Zone Lymphoma (Gastric or Duodenal)
Keywords: Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma, follicular
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: International Lymphoma Radiation Oncology Group (ILROG)
First posted: 2019-09-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

Detailed description: * Prove the effectiveness of 20 Gy (and non-inferiority to actually recommended 30 Gy) with respect to response rate 6 months after radiotherapy.
* Correlation of blood serum biomarker levels with lymphoma response to radiation treatment
* Recording of survival rates, quality of life (QoL), radiogenic toxicities and inflammation relevant molecules in blood serum.

Primary Objective:

Response rate 6 months after end of treatment, 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 Objectives:

QoL according to EORTC (QLQ C30 and STO22). EFS=Event-free survival (time to any failure or death from any cause, patients in CR or PR), LSS=lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients), PFS=Progression-free survival (time to progression of lymphoma or death from any cause, all patients), OS=overall survival (time to death from any cause, all patients). Level of cytokines IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins. Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA.

Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)

-Assessment of safety: Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Eligibility 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

Primary outcomes:
measure: Response rate
timeFrame: Until 6 months after end of treatment
Secondary outcomes:
measure: QoL #1
timeFrame: Until 6 months after end of treatment
measure: QoL #2
timeFrame: Until 6 months after end of treatment
measure: EFS
timeFrame: Until at least 6 months after end of treatment
measure: LSS
timeFrame: Until at least 6 months after end of treatment
measure: PFS
timeFrame: Until at least 6 months after end of treatment
measure: OS
timeFrame: Until at least 6 months after end of treatment
measure: Level of cytokines in blood serum
timeFrame: Until 6 months after end of treatment
measure: Acute and chronic toxicities
timeFrame: Until at least 6 months after end of treatment
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Department of Radiation Oncology
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Radiation Oncology University Hospital Muenster
name: Prof. Dr. H. Th. Eich
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology University Hospital Muenster
name: Priv. Doz. Dr. G. Reinartz
role: PRINCIPAL_INVESTIGATOR
References: