Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Radiation-induced Xerostomia; Nasopharyngeal Carcinoma

Treatments: Radiation: superficial parotid lobe-sparing intensity-modulated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05020067

SPLS-IMRT NPC

Details and patient eligibility

About

This is a prospective phase II clinical randomized controlled study, the purpose of this study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC patients.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:1) newly diagnosed, histologically confirmed World Health Organization (WHO) type II-III NPC; 2) stage I-IVa (T1-4 N0-3M0) according to the staging system of the 8th American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC); 3) no prior antitumor therapy; 4) no tumor involvement in salivary gland; 5) no parotid glands disorder and no history of parotid glands surgery; 6) ages between 18 and 70 years; 7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and 8) adequate organ function Exclusion Criteria: 1) used salivary stimulating or protecting agent; 2) metachronous or synchronous malignancy; 3) pregnancy or lactation; or 4) severe comorbidities. The pretreatment evaluation included a complete history and physical examination, nasopharyngoscopy, chest X-ray, complete blood count, liver and renal biochemistry, and magnetic resonance imaging (MRI) of the head and neck.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

SPLS-IMRT

Experimental group

Description:

The superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30%

Treatment:

Radiation: superficial parotid lobe-sparing intensity-modulated radiotherapy

C-IMRT

No Intervention group

Description:

The entire parotid gland was delineated as an OAR, and V36 (the percentage volume receiving 36 Gy or more) in the entire parotid gland was constrained to be less than 40%