Xerostomia-optimised IMRT Versus Standard IMRT in NPC

NCT06282497 | Recruiting DMC

• 1 other identifier: ZSCPH-003
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Regional recurrence free survival

  From the date of randomization to regional recurrence or any death

  3 years

Secondary Outcomes (6)

• Overall survival

  3 years

• Local recurrence free survival

  3 years

• Distant metastasis-free survival

  3 years

• Progression free survival

  3 years

• Acute toxicities

  From the start of treatment until 3 months post treatment

Study Arms (2)

Study Group

EXPERIMENTAL

optimised neck CTV delineation

Radiation: Optimised neck CTV

Control Group

ACTIVE COMPARATOR

standard neck CTV delineation

Radiation: standard neck CTV

Interventions

Optimised neck CTV RADIATION

neck CTV delineation extends from the lateral process of C1

Study Group

standard neck CTV RADIATION

neck CTV delineation extends from skull base

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
• No contraindications to chemotherapy or radiotherapy;
• Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Sign the consent form.

You may not qualify if:

• Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;
• ≥4 nodal regions of ipsilateral neck involvement;
• 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;
• Previous malignancy or other concomitant malignant disease;
• Pregnancy or lactation.

Sponsors & Collaborators

• Zhongshan People's Hospital, Guangdong, China: lead

Study Sites (1)

Zhongshan City People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

Study Officials

• Gui-qiong Xu, MD

  Zhongshan People's Hospital, Guangdong, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gui-qiong Xu, MD

CONTACT

+8613528109888; donna_shee@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: October 23, 2023
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2029
• Last Updated: May 1, 2024

Record last verified: 2024-02

Locations

CN (1)