Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma (DOBL) - A Randomised Phase III Non- Inferiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Event Free Survival
研究概览
简要总结
The purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25 fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36 Gy in 20 fractions.
The role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing improvement in overall survival and progression free survival with combined modality treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55 Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid abnormalities and secondary breast cancer are being increasingly identified. Hence it is essential to optimize the dose of radiotherapy for lower toxicity without compromising on efficacy.
详细描述
Patients who fit the eligibility criteria will be screened for the trial. Patients who consent to participate in the trial will be registered into the trial prior to the start of chemotherapy.
Patient registration / randomization procedure
After completion of staging, the patient is informed about this trial after checking the eligibility checklist.
The patient is informed about this trial, including the following main points: title and aim of the trial, nature of the treatment, side effects, reason for randomization, passing on of data and material samples and the patient's freedom to decide.
The patient receives an information brochure and an informed consent form. The written consent to participate in the trial and to randomization, if needed, in the presence of a witness takes place at least 24 hours after patient briefing. The signed original consent form and the record of the briefing remain in the patient's files. The patient receives a copy of each document. If after completion of staging the patient is qualified for a trial and gives written informed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological Diagnosis of NHL- DLBCL.
- •Eligible for RT after R-CHOP.
- •18 - 65 years.
- •Stage I-IV.
- •Patients should receive at least 4 cycles of R-CHOP chemotherapy.
- •Patients with all extranodal disease except the ones mentioned in the
排除标准
- •Able to understand and willing to provide informed consent for participation in the trial.
- •Exclusion Criteria:
- •HIV positive status.
- •Relapse or progression of disease during chemotherapy.
- •Prior history of chemotherapy
- •Prior history of radiotherapy.
- •Systemic lymphomas with CNS involvement.
- •Primary extranodal Testicular Lymphomas.
- •Primary extranodal central nervous system (CNS) Lymphomas.
- •Primary extranodal Stomach DLBCL
- •Primary extranodal Intestinal DLBCL
- •Patients >3 extranodal sites
研究组 & 干预措施
Standard Arm
45 Gy in 25 fractions of 1.8 Gy per fraction over 5 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)
干预措施: Standard Arm (Radiation)
Experimental Arm
36 Gy in 20 fractions of 1.8 Gy per fraction over 4 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)
干预措施: Experimental Arm (Radiation)
结局指标
主要结局
Event Free Survival
时间窗: 2 years
From the time of randomization till relapse or progression or death due to any cause or death due to disease. Assessment by physiological parameter
次要结局
- Acute toxicity(During radiation to 6 weeks from the end of radiation)
- Local Control Rate(2 years)
- Overall Survival(2 years)
- Overall response rate(3 months)
- Late toxicity(2 years)
- Quality of Life scores(2 years)
研究者
Jayant Sastri Goda
Associate Professor
Tata Memorial Hospital