- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07628738
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
5. juni 2026 opdateret af: CAI GANG, Ruijin Hospital
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
39
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Gang Cai, MD
- Telefonnummer: 602400 +86-021-64370045
- E-mail: cg11855@rjh.com.cn
Undersøgelse Kontakt Backup
- Navn: Shu-Bei Wang, MD
- Telefonnummer: 602400 +86-021-64370045
- E-mail: wangshubei@163.com
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200025
- Rekruttering
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
Kontakt:
- Shu-Bei Wang, MD
- Telefonnummer: 602400 +86-021-64370045
- E-mail: wangshubei@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: research arm
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
2-year local regional recurrence-free survival rate
Tidsramme: 2 year
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Gang Cai, MD, Ruijin Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. maj 2032
Studieafslutning (Anslået)
1. maj 2034
Datoer for studieregistrering
Først indsendt
1. juni 2026
Først indsendt, der opfyldte QC-kriterier
1. juni 2026
Først opslået (Faktiske)
5. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026360
Plan for individuelle deltagerdata (IPD)
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