Online adaptive radiotherapy for nasopharyngeal carcinoma
Artificial Intelligence Empowered Online Adaptive Radiotherapy Versus Conventional Radiotherapy in Non-metastatic Nasopharyngeal Carcinoma: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial
This study is testing if a new type of online adaptive radiotherapy can help people with nasopharyngeal carcinoma live longer and feel better compared to traditional radiotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 494 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06516133 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial involves treatment-naïve patients with nasopharyngeal carcinoma who will be randomly assigned to receive either online adaptive radiotherapy (ART) with a smaller planning target volume (PTV) margin or conventional radiotherapy with a standard PTV margin. The study aims to compare the locoregional recurrence-free survival rates, adverse events, and quality of life between the two treatment approaches. By utilizing online ART, the trial seeks to determine its effectiveness in reducing radiation toxicity while maintaining treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with newly diagnosed nasopharyngeal carcinoma and no evidence of distant metastasis.
Not a fit: Patients with histological types other than non-keratinizing carcinoma or those requiring palliative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes and reduce side effects for patients with nasopharyngeal carcinoma.
How similar studies have performed: Other studies have shown promise with adaptive radiotherapy approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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. Eastern Cooperative Oncology Group (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: 1. 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yu-xian Yang, MD
- Email: yangyx1@sysucc.org.cn
- Phone: +86 147 4892 2370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.