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Phase III Trial of concurrent chemoradiotherapy followed by TPC adjuvant chemotherapy versus concurrent chemoradiotherapy followed by PF adjuvant chemotherapy in High Risk Nasopharyngeal Carcinoma

Phase III Trial of concurrent chemoradiotherapy followed by TPC adjuvant chemotherapy versus concurrent chemoradiotherapy followed by PF adjuvant chemotherapy in High Risk Nasopharyngeal Carcinoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019373
Enrollment
Unknown
Registered
2018-11-07
Start date
2019-02-01
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Nasopharyngeal Carcinoma

Interventions

Group 1:CCRT + TPC
Group 2:CCRT + PF

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients with histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type); (2) Diagnosis with anyT N2-3M0(according to the American Joint Committee on Cancer(AJCC) 8th edition)and plasma EBVDNA=1500copies/ml; (3) ECOG Performance status =2; (4) Without prior malignancy; (5) Aged 18-65 years old; (6) Adequate liver function : Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN), alkaline phosphatase (ALP) =2.5×ULN, total bilirubin = ULN; (7) Adequate renal function: creatinine clearance =80 ml/min; (8) Adequate marrow: absolute neutrophil count =4000/µL, hemoglobin =90g/L and platelet count =100000/µL; (9) Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion criteria

Exclusion criteria: (1) History of previous radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes; (2) Diagnosis with distant metastasis at presence; (3) Pregnancy or lactation; (4) With mental, social, family or geographic factors that will affect the follow-up; (5) Participants enrolled in ongoing clinical trails; (6) Known to be allergic to potentially used chemotherapy drugs; (7) With sever infection and internal disease; (8) Any severe organ disfunction, for example, cardiopulmonary insufficiency, hepatic and renal insufficiency; (9) With factors that will affect the administration, distribution,metabolism or evacuation; (10) Using immunosuppressive agents after organ transplantation.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Countries

China

Contacts

Public ContactYan-Qun Xiang

Sun Yat-sen University Cancer Center

xiangyq@sysucc.org.cn+86 18666096623

Outcome results

None listed

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