Skip to content

A multicenter randomized controlled non-inferior phase III clinical study of radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma with EBV DNA complete response after GP regimen induction chemotherapy

A multicenter randomized controlled non-inferior phase III clinical study of radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma with EBV DNA complete response after GP regimen induced chemotherapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049340
Enrollment
Unknown
Registered
2021-07-30
Start date
2021-07-27
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Nasopharyngeal carcinoma

Interventions

Treatment group A:Radiotherapy alone
Treatment group B:Concurrent chemotherapy

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 70 years; 2.Pathologically diagnosed as WHO type II/III nasopharyngeal carcinoma; 3.AJCC 8th T3-4N0-1M0 or T1-4N2-3M0 patients and expected to survive at least 6 months; 4.ECOG PS score: 0-1 points; 5.EBV DNA can be detected before treatment. After 1 course of GP regimen (gemcitabine + cisplatin) induction chemotherapy, EBV DNA is completely remitted (below the detection limit) and there is no rebound after the second and third courses of GP regimen treatment; 6.The main organs function normally and meet the following requirements: Blood routine: (1)HB>=90g/L; (2)ANC >=1.5x10^9/L; (3)PLT >=100x10^9/L. The biochemical inspection meets the following standards: (1)BIL =60ml/min (Cockcroft-Gault formula). 7.The patient signs an informed consent form and is willing to complete the study according to the plan.

Exclusion criteria

Exclusion criteria: 1.Clinical examination or imaging examination found that there is distant metastasis; 2.Head and neck have received radiotherapy or surgery; 3.A history of other malignant tumors or multiple primary tumors at the same time (except skin basal cell carcinoma); 4.Positive pregnancy test for women of childbearing age; 5.Concomitant diseases or conditions affect the safety of patients during normal enrollment or research; 6.Active mental disorders or other mental disorders that affect the patient's ability to sign informed consent and understand; 7.Uncontrolled active infection.

Design outcomes

Primary

MeasureTime frame
progression-free survival;overall survival;objective remission rate;

Countries

China

Contacts

Public ContactDu Chengrun

Fudan University Shanghai Cancer Center

duchengrun@qq.com+86 18121299458

Outcome results

None listed

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