Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy, Chemotherapy, Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Artificial Intelligence Empowered Online Adaptive Radiotherapy Versus Conventional Radiotherapy in Non-metastatic Nasopharyngeal Carcinoma: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial
Overview
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.
Interventions
- Radiation Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy
Radiation: Complete the full course of radiotherapy using the original treatment plan. Planning target volume (PTV) margin: 3mm; - Drug Chemotherapy
Chemotherapy: If given, platinum-based. - Radiation Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy
Radiation: During the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of patients. planning target volume (PTV) margin: smaller. - Drug Chemotherapy
Chemotherapy: If given, platinum-based
Primary outcome measures
- Locoregional recurrence-free survival [Time frame: 3-year]
Secondary outcome measures (6)
- Overall survival [Time frame: 3-year]
- Distant metastasis free survival [Time frame: 3-year]
- Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0) [Time frame: 3 months]
- Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0). [Time frame: 3-year]
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0) [Time frame: From baseline to 3 years post-radiotherapy]
- and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.) [Time frame: From baseline to 3 years post-radiotherapy]
Eligibility criteria
Inclusion criteria
- Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO), pathological classification.
- No evidence of distant metastasis (M0).
- Age between 18 and 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score:0-1.
- Undergoing radical intensity-modulated radiation therapy (IMRT).
- No claustrophobia and able to remain in a fixed position for at least 30 minutes
- 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
- Histological types include squamous cell carcinoma or basal cell carcinoma.
- Radiation therapy intended for palliative care.
- History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia.
- Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment.
- Previous radical radiotherapy for nasopharyngeal cancer.
- Primary and neck metastatic lesions treated with chemotherapy or surgery.
- 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.
- Initial assessment of treatment efficacy more than 120 days after the end of radiotherapy.
- Inability to undergo enhanced magnetic resonance imaging due to contrast agent allergies, claustrophobia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06516133 · SL-B2023-685-02