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Artificial intelligence empowered online adaptive radiotherapy versus conventional radiotherapy in non-metastatic nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial

Artificial intelligence empowered online adaptive radiotherapy versus conventional radiotherapy in non-metastatic nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079473
Enrollment
Unknown
Registered
2024-01-04
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

ART group:Implementing adaptive radiotherapy
Non-ART group:No adaptive radiotherapy

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO, pathological classification). 2.No evidence of distant metastasis (M0). 3.Age between 18 and 70 years. 4.ECOG performance status score:0-1. 5.Undergoing radical intensity-modulated radiation therapy (IMRT). 6.No claustrophobia and able to remain in a fixed position for at least 30 minutes 7.Patients must be informed of the main content of this study, sign an informed consent form, and be willing and able to comply with the treatment, follow-up plan, laboratory tests, and other requirements specified in the study protocol.

Exclusion criteria

Exclusion criteria: 1.WHO histological types include squamous cell carcinoma or basal cell carcinoma. 2.Radiation therapy intended for palliative care. 3.History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia. 4.Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment. 5.Previous radical radiotherapy for nasopharyngeal cancer. 6.Primary and neck metastatic lesions treated with chemotherapy or surgery. 7.Presence of other serious underlying diseases that may pose a greater risk or affect compliance with the trial. Examples include unstable cardiac diseases requiring treatment, renal diseases, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and psychiatric disorders. 8.Initial assessment of treatment efficacy more than 120 days after the end of radiotherapy. 9.Inability to undergo enhanced magnetic resonance imaging due to contrast agent allergies, claustrophobia.

Design outcomes

Primary

MeasureTime frame
3-year locoregional recurrence-free survival;

Secondary

MeasureTime frame
3-year overall survival;3-year distant metastatic-free survival;Incidence and severity of 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