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NCT Number: 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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Shu-Bei Wang, MD

CONTACT

[email protected]

+86-021-64370045 ext. 602400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 2-year local regional recurrence-free survival rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Cai, MD

CONTACT

[email protected]

+86-021-64370045 ext. 602400

Shu-Bei Wang, MD

CONTACT

[email protected]

+86-021-64370045 ext. 602400

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2032
Study completion
2034
First posted
Jun 5, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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