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A single-center real world study of intensity modulated radiotherapy for local nasopharyngeal residual lesions after radiotherapy for nasopharyngeal carcinoma

A single-center real world study of intensity modulated radiotherapy for local nasopharyngeal residual lesions after radiotherapy for nasopharyngeal carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058299
Enrollment
Unknown
Registered
2022-04-04
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-12-19

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:Dose of intensity modulated radiotherapy for local residual lesions

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. There is no gender limitation, aged 18 to 70 years; 2. KPS>=70 points; 3. Patients who did not receive antitumor therapy for the first time and had no history of other malignant tumors; WHO II and III nasopharyngeal carcinoma confirmed by pathology; 4. AJCC 8th Installment I-IVA; 5. The initial treatment was radiotherapy with or without chemotherapy: conventional segmented intensity modulated radiotherapy (prescription dose: PGTV: 2.12~2.2Gy/fx33F, 5f/w, total dose: 69.96~72.6Gy/6.5w; PTV1: 1.8-2.0Gy /fx33F, 5f/w, total dose: 59.4-66.0Gy /6.5w; PTV2: 1.8~2.0Gy/fx25~28F, 5f/w, total dose: 50~56Gy/5~5.5w); Chemotherapy regimen was based on platinum; 6. Residual lesions of nasopharynx (nasopharynx, skull base, parapharynx) were identified by nasopharyngeal PET/MR Examination at the end of primary radiotherapy, and no distant metastasis was found; 7. No serious dysfunction of heart, lung, liver, kidney and other important organs: (1) Normal liver and kidney function: AST and ALT =60 mL/min; (2) Adequate bone marrow function: peripheral blood white blood cells >4.0x10^9/L, neutrophils >2.0x10^9/L, hemoglobin >90 g/L, platelet >100x10^9/L; 8. Expected survival of not less than 12 months; 9. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients, patients of childbearing age without contraception; 2. Combined with residual regional tumors (cervical lymph nodes, excluding postpharyngeal lymph nodes); 3. Patients with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes mellitus; 4. Patients without regular follow-up requirements.

Design outcomes

Primary

MeasureTime frame
Local Regional Progression Free Survival Rate;

Secondary

MeasureTime frame
Complete Remission Rate;Local Recurrence Free Survival;Regional Recurrence Free Survival;Distant Metastasis Free Survival;Disease Progression Free Survival;Safety Evaluation;Quality of Life;

Countries

China

Contacts

Public ContactLyu Xing

Sun Yat-sen University Cancer Center

lvxing@sysucc.org.cn+86 15920182400

Outcome results

None listed

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