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

Обзор

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.

Вмешательства

• Лучевая терапия reduced-intensity radiotherapy
  The patients will receive radiotherapy. The target volume, determined based on the involvement of the primary tumor and sites of metastasis, will include the nasal cavity or Waldeyer's ring, with or without bilateral cervical lymphatic drainage areas. The prescribed dose is 45 Gy in 25 fractions, at 1.8 Gy per fraction per day, five days per week, to be completed within five weeks.

Первичные конечные точки

• 2-year local regional recurrence-free survival rate [Срок оценки: 2 year]

Критерии участия

Критерии включения

• 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 0-1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Публикации

• Yang Y, Zhang YJ, Zhu Y, Cao JZ, Yuan ZY, Xu LM, Wu JX, Wang W, Wu T, Lu B, Zhu SY, Qian LT, Zhang FQ, Hou XR, Liu QF, Li YX. Prognostic nomogram for overall survival in previously untreated patients with extranodal NK/T-cell lymphoma, nasal-type: a multicenter study. Leukemia. 2015 Jul;29(7):1571-7. doi: 10.1038/leu.2015.44. Epub 2015 Feb 20. PMID 25697894
• Jaffe ES, Chan JK, Su IJ, Frizzera G, Mori S, Feller AC, Ho FC. Report of the Workshop on Nasal and Related Extranodal Angiocentric T/Natural Killer Cell Lymphomas. Definitions, differential diagnosis, and epidemiology. Am J Surg Pathol. 1996 Jan;20(1):103-11. doi: 10.1097/00000478-199601000-00012. PMID 8540601

Идентификаторы

NCT: NCT07628738 · 2026360

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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