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NCT Number: NCT06282497

Xerostomia-optimised IMRT Versus Standard IMRT in NPC

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan City People's Hospital

Zhongshan, Guangdong, 528403, China

Location status: Recruiting

Location contact

Gui-qiong Xu, MD

CONTACT

[email protected]

+8613528109888

About this study

Xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of NPC patients still experience varying degrees of xerostomia post-IMRT. Among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. Studies have revealed that xerostomia post-IMRT is mainly dependent on the irradiation dose of the parotid glands. Clinical target volumes (CTV) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. Consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 Gy to 43.9 Gy in most reports. Retrospective studies reveal that the lateral process of C1 is a suitable cranial edge for neck CTV delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and QoL of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Regional recurrence free survival

    Time frame: 3 years

    From the date of randomization to regional recurrence or any death

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

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

  2. Local recurrence free survival

    Time frame: 3 years

    From the date of randomization to local recurrence or any death

  3. Distant metastasis-free survival

    Time frame: 3 years

    From the date of randomization to distant metastasis or any death

  4. Progression free survival

    Time frame: 3 years

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

  5. Acute toxicities

    Time frame: From the start of treatment until 3 months post treatment

    Assessed with CTCAE v5.0

  6. Late toxicities

    Time frame: 3 years post treatment

    Assessed with Radiation Therapy Oncology Group criteria and the CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Gui-qiong Xu, MD

CONTACT

[email protected]

+8613528109888

Sponsors and collaborators

Lead sponsor

Zhongshan People's Hospital, Guangdong, China

Other

Registry information

Official study title

Xerostomia-optimised Intensity-modulated Radiotherapy Versus Standard Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Patients:a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Feb 28, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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