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Recruiting Phase 3 NCT06516133

Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma

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Plain-language summary for patients

Trial Parameters

Condition Nasopharyngeal Carcinoma
Sponsor Sun Yat-sen University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 494
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-05-17
Completion 2030-12
Interventions
Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapyChemotherapyIntensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy

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Brief Summary

In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.

Eligibility 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 carc

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