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IMRTradiotherapy alone versus IMRT radiotherapy plus concurrent chemoradiotherapy in stage II and III nasopharyngeal carcinoma: a phase II, prospective, noninferiority clinical trial

IMRTradiotherapy alone versus IMRT radiotherapy plus concurrent chemoradiotherapy in stage II and III nasopharyngeal carcinoma: a phase II, prospective, noninferiority clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16010191
Enrollment
Unknown
Registered
2016-12-20
Start date
2016-12-20
Completion date
Unknown
Last updated
2017-04-18

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:IMRT alone
group 2:IMRT pius cisplatin concurrent chemoradiotherapy

Sponsors

651 East Dongfeng Road, East, Guangzhou, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologic diagnosis of nasopharyngeal carcinoma (WHO II or III); 2. stage II and III (AJCC 7th edition); 3. pre-treament EB DNA level=70; 8. Hepatic function: STB, CB=4.0*10^9/L, ANC>=1.5*10^9/L; PLT >=100*10^9/L; HB>=90g/L; 10. Voluntary to participate sign informed consent document; 11. Compliance with regular follow-up; 12. Compliance with the test requirements.

Exclusion criteria

Exclusion criteria: 1. Previously treated (surgery, chemotherapy, radiotherapy, EGFR targeted therapy or immunotherapy); 2. Distant metastases; 3. Pregnancy; 4. Refuse to sign informed consent document; 5. Uncontrolled seizure disorder or other serious neurologic disease; 6. in other clinical trial; 7. Allergic to Chemotherapy drugs; 8. With severe complications or active infection; 9. Organs dysfunction(heart,lungs and etc); 10. TBIL>1.5(ULN)AST or ALT>2.5 ULN and ALP>2.5 ULN; 11. Mental disorders, chronic diarrhea, ascites or pleural effusion; 12. Immunosuppressive therapy for other diseases; 13. History of other cancer.

Design outcomes

Primary

MeasureTime frame
Progress free survival;

Secondary

MeasureTime frame
Complete remission rate;Overall survival;Quality of life;

Countries

China

Contacts

Public ContactGuo Xiang

Department of Nasopharyngeal, Sun Yat-sen University Cancer Centre

guoxiang@sysucc.org.cn+86 13902251681

Outcome results

None listed

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