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Xerostomia-optimised IMRT Versus Standard IMRT in NPC

ConditionNasopharyngeal Carcinoma ,Xerostomia,Radiotherapy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Optimised neck CTV

    Radiation

    neck CTV delineation extends from the lateral process of C1

  • standard neck CTV

    Radiation

    neck CTV delineation extends from skull base

Treatment groups

524 Participants
are divided into 2 treatment groups
Group A: Study GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Regional recurrence free survival

From the date of randomization to regional recurrence or any death

Time frame
3 years

Secondary outcomes

1

Overall survival

From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up

Time frame
3 years
2

Local recurrence free survival

From the date of randomization to local recurrence or any death

Time frame
3 years
3

Distant metastasis-free survival

From the date of randomization to distant metastasis or any death

Time frame
3 years
4

Progression free survival

From the date of randomization to local or regional recurrence, distant metastasis or any death

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongshan People's Hospital, Guangdong, China

Lead sponsor

Source ClinicalTrials.gov
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