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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| research arm | Experimental | reduced-intensity radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduced-intensity radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year local regional recurrence-free survival rate | The percentage of patients who, after completing treatment, remain alive without experiencing a recurrence of cancer in the same anatomical region where the original tumor was located (local) or in the nearby lymph nodes (regional) within two years from the start of treatment or from the date of achieving remission. | 2 year |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu-Bei Wang, MD | Contact | +86-021-64370045 | 602400 | wangshubei@163.com |
| Gang Cai, MD | Contact | +86-021-64370045 | 602400 | cg11855@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Cai, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25697894 | Background | 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. | |
| 8540601 |
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|
| 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. |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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