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Artificial Intelligence-Assisted All-In-One Radiotherapy for Nasopharyngeal Carcinoma: A Phase II, Single-Center, Single-Arm Combined Real-World Data Parallel-Controlled Trial

Artificial Intelligence-Assisted All-In-One Radiotherapy for Nasopharyngeal Carcinoma: A Phase II, Single-Center, Single-Arm Combined Real-World Data Parallel-Controlled Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079384
Enrollment
Unknown
Registered
2024-01-02
Start date
2024-01-05
Completion date
Unknown
Last updated
2024-01-08

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:All-in-one radiotherapy

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed diagnosis of nasopharyngeal carcinoma with pathologic staging of non-keratinizing carcinoma. 2. No evidence of distant metastasis. 3. Age 18-85 years. 4.ECOG physical status score 0~1. 5. Radical IMRT radiotherapy is required. 6. Tolerates 30 minutes of lying still in a treatment bed. 7. Patients must be informed of the all points of the study and sign an informed consent form, and must be willing and able to comply with the treatment, follow-up protocol, laboratory tests, and other requirements as specified in the study protocol.

Exclusion criteria

Exclusion criteria: 1. The pathological types are keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. The purpose of radiation therapy is palliative treatment. 3.The tumor invades the dura mater, brainstem, temporal lobe, and spinal cord. 4. Other malignant tumors, except for adequately treated basal cell carcinoma or squamous cell carcinoma, as well as cervical carcinoma in situ. 5. Women who are pregnant or breastfeeding (pregnancy testing should be considered for women of childbearing age; effective contraception should be emphasized during treatment). 6. Patients who have received previous radiation therapy before undergoing curative radiotherapy for nasopharyngeal carcinoma. 7. Primary and neck metastatic lesions that have received chemotherapy or surgical treatment. 8. Patients with other severe underlying diseases that may pose significant risks or affect compliance with the trial. Examples include unstable cardiac diseases requiring treatment, kidney diseases, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and psychiatric disorders, among others. 9. The first assessment of treatment efficacy after completion of therapy occurs more than 180 days after the end of radiotherapy. 10. Inability to undergo contrast-enhanced magnetic resonance imaging due to allergies to contrast agents or conditions such as claustrophobia.

Design outcomes

Primary

MeasureTime frame
2-year locoregional recurrence-free survival rate;

Secondary

MeasureTime frame
2-year overall survival;2-year local recurrence-free survival;2-year regional recurrence-free survival;2-year distant metastatic-free survival;Short term efficacy;Dosimetric evaluation;adverse effects;Quality of life;

Countries

China

Contacts

Public ContactYing Sun

Sun Yat-sen University Cancer Center

sunying@sysucc.org.cn+86 136 8885 6258

Outcome results

None listed

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