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Prospective multicenter clinical study of IMRT alone versus concurrent chemoradiotherapy in the treatment of moderate risk nasopharyngeal carcinoma

Prospective multicenter clinical study of IMRT alone versus concurrent chemoradiotherapy in the treatment of moderate risk nasopharyngeal carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017132
Enrollment
Unknown
Registered
2018-07-13
Start date
2018-07-13
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Nasopharyngeal carcinoma

Interventions

Experimental group:IMRT alone
Contrast group:Concurrent chemoradiotherapy with cisplatin

Sponsors

Affiliated Hospital of Guilin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologic diagnosis of non-keratinizing nasopharyngeal carcinoma(according to the pathological classification of WHO); 2. Tumor staged as T1-2N1/T2-3N0(according to the 8th AJCC edition)(appendix I); 3. No evidence of distant metastasis(M0); 4. Functional state:KPS>=70(appendix II); 5. Normal bone marrow function:leucocyte count > 4 * 10^9/L, hemoglobin of male > 110g/L and hemoglobin of female > 110g/L, platelet count > 100 * 10^9/L; 6. Normal liver function:ALT and AST 60 ml/min; 8. All patients must be informed of the investegational nature of this study and signed the written informed consent.

Exclusion criteria

Exclusion criteria: 1. The lymph node capsule of cervical lymph node was invaded, the maximum diameter of transverse section of cervical lymph nodes was greater than or equal to 3cm,and the positive lymph nodes were located in the IV region and / or Vb region; 2. The pathological type was keratinized squamous cell carcinoma or basosquamous cell carcinoma according to the pathological classification of WHO; 3. Aged > 70 or 1.5 * ULN),and mental illness.

Design outcomes

Primary

MeasureTime frame
Progress-free survival;Toxicities;

Secondary

MeasureTime frame
Distant metastasis-free survival;Locoregional relapse-free survival;Overall Survival;

Countries

China

Contacts

Public ContactWei Jiang

Affiliated Hospital of Guilin Medical University, Guilin, PR China

weijiang@glmc.edu.cn+86 13788561863

Outcome results

None listed

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