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Phase 3 Trial Comparing IMRT or IMPT plus CIRT for Patients With Locally Advanced NPC

Phase 3 Trial Comparing IMRT or IMPT plus CIRT for Patients With Locally Advanced NPC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097823
Enrollment
Unknown
Registered
2025-02-26
Start date
2025-02-26
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal carcinoma

Interventions

Control group:IMRT+IMCT
Study Group:IMPT+IMCT

Sponsors

Shanghai Proton and Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial. 2.Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type). 3.Diagnosed with stage with III-Iva (exclude T3N0) (AJCC 8th stage); 4.Age > 18 and = 1500/uL b. Platelets >= 100,000/uL c. Hemoglobin >= 9 g/dL d. Serum creatinine = 60 mL/min e. Total bilirubin <= 1.5×ULN f. AST vs. ALT <= 2.5×ULN; 7.Willing to accept adequate contraception for women with childbearing potential.

Exclusion criteria

Exclusion criteria: 1.Presence of distant metastasis. 2.Received radiotherapy for head and neck before. 3.Received surgery(except for biopsy) for primary lesion or cervical lymph node. 4.Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors. 5.Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of endpoint. 6.Accompanied with severe major organ dysfunction. 7.Presence of mental disease that may influence the understanding of informed consent.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Countries

China

Contacts

Public ContactJiyi Hu

Shanghai Proton and Heavy Ion Center

jiyi.hu@sphic.org.cn+86 21 38296666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026