NCT07628738招募中2 期
A Prospective Clinical Study on Reduced-intensity Radiotherapy for Stage I/II Low-risk Nasal-type NK/T-cell Lymphoma Achieving Complete Remission After Chemotherapy
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of reduced-intensity radiotherapy for stage I/II low-risk nasal-type NK/T-cell lymphoma that has achieved complete remission after chemotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient voluntarily agrees to participate in this study and signs the informed consent form.
- •Age ≥ 18 years and ≤ 75 years.
- •Pathologically confirmed diagnosis of nasal-type NK/T-cell lymphoma.
- •Clinical stage I-II disease confirmed by PET-CT or MRI.
- •The lymphoma has been treated with an asparaginase-based chemotherapy regimen.
- •Presence of 0-1 prognostic risk factors (risk factors: age > 60 years, ECOG score ≥ 2, elevated LDH, elevated PTI, stage II).
- •Imaging assessment shows complete clinical remission after chemotherapy.
- •ECOG-PS score of 0-
- •Expected survival of ≥ 12 months.
- •Normal function of major organs, meeting the following criteria:
- •Hematology: absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 80 × 10⁹/L; hemoglobin ≥ 80 g/L.
- •Biochemistry: total bilirubin < 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance > 50 mL/min.
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use highly effective contraception during the study period and for 120 days after the last dose. For male subjects with female partners of childbearing potential, they must be surgically sterile or agree to use highly effective contraception during the study period and for 120 days after the last dose.
排除标准
- •A previous or concurrent diagnosis of another malignancy, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
- •Presence of severe medical conditions, or concomitant diseases or situations that may affect the patient's eligibility for enrollment or compromise safety during the study period.
- •Pregnant or breastfeeding women.
- •Presence of active mental disorders or other psychiatric conditions that may affect the patient's ability to sign the informed consent form or to comprehend the study information.
- •Patients deemed by the investigator to have poor compliance.
- •Distant metastasis confirmed by pathology or imaging.
- •As judged by the investigator, the patient has other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant treatment, significant laboratory abnormalities, or family or social factors that could compromise patient safety.
研究组 & 干预措施
research arm
Experimental
reduced-intensity radiotherapy
干预措施: reduced-intensity radiotherapy (Radiation)
研究者
CAI GANG
Principal Investigator
Ruijin Hospital
研究点 (1)
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