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Clinical research of stereotactic body radiotherapy combined with cetuximab in the treatment of oligometastasis of nasopharyngeal carcinoma

Clinical research of stereotactic radiotherapy combined with cetuximab in the treatment of oligometastasis of nasopharyngeal carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015589
Enrollment
Unknown
Registered
2018-04-10
Start date
2018-05-01
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Nasopharyngeal carcinoma

Interventions

Case series:chemotherapy +SBRT+ cetuximab

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged=18; 2. The general situation is good, KPS score > 70 (Appendix I); 3. Nasopharyngeal carcinoma was confirmed by histology or cytology; 4. Patients with oligometastases who had ever received radiotherapy or chemotherapy and achieved disease control (CR, PR or SD), and nonmetastatic patients receiving treatment 5 years later; 5. Appropriate hematological parameters and liver and kidney function: Neutrophil absolute value is more than 1.5 * 10^9/L; The platelet count is over 75 * 10^9/L; Serum total bilirubin is less than 1.5 * upper limit of normal; AST and ALT is less than 2.5 * upper limit of normal (if abnormal liver function is caused by tumor, AST and ALT is less than 5 * upper limit of the normal value); Serum creatinine is less than 1.5 * upper limit of the normal value calculated by Coclcroft-Gault formula creatinine clearance rate greater than 50mL/min; 6. The expected survival time is more than 3 months; 7. Patients must be informed the content of this research and signed the informed consent before treatment.

Exclusion criteria

Exclusion criteria: (1) Hypersensitivity to cetuximab; (2) Losers who had received 1 or more palliative chemotherapy regimens; (3) Peripheral neuropathy is more than CTC grade 2; (4) Neurological or mental abnormalities that affect cognitive ability; (5) Patients with central nervous system metastasis; (6) Uncontrolled accompanying diseases in the first 6 months, including unstable angina pectoris, acute myocardial infarction, cerebrovascular accident, etc; (7) Woman who is pregnant or lactation or having fertility without taking contraceptive measures; (8) The history of other malignant tumors, but the period of disease free survival is not more than 5 years; (9) Combined with other antitumor treatment or other intervention clinical trials at the same time; (10) The patients for the psychological and family living society are not compatible with this study.

Design outcomes

Primary

MeasureTime frame
overall survival, OS;

Secondary

MeasureTime frame
progression-free survival, PFS;

Countries

China

Contacts

Public ContactYan Li

West China Hospital, Sichuan University

yy1240@163.com+86 028-85423278

Outcome results

None listed

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