Xerostomia-optimised IMRT Versus Standard IMRT in NPC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhongshan People's Hospital, Guangdong, China
About this trial
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients
Eligibility criteria
Qualifiers
Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
All genders, range from 18-70 years old;
ECOG score 0-1;
Clinical stage I-IVa (AJCC/UICC 8th);
Disqualifiers
Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;
Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1;
Parotid lymph node and/or parotid gland involvement;
History of parotid disease or surgery;
Trial design
Treatments tested in this trial
- Optimised neck CTV
- standard neck CTV
Treatment groups
524 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov