Status:
RECRUITING
Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT06516133
Start Date
May 17 2024
End Date
December 1 2030
Last Update
July 23 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060