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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
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)
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Response rate
时间窗: Until 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)
次要结局
- QoL #2(Until 6 months after end of treatment)
- QoL #1(Until 6 months after end of treatment)
- EFS(Until at least 6 months after end of treatment)
- LSS(Until at least 6 months after end of treatment)
- PFS(Until at least 6 months after end of treatment)
- OS(Until at least 6 months after end of treatment)
- Level of cytokines in blood serum(Until 6 months after end of treatment)
- Acute and chronic toxicities(Until at least 6 months after end of treatment)