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NCT Number: NCT05780372

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

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. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Radiotherapy; Complications Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, China

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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 ≥ 9g/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

  • Neck lymph nodes exist skipping metastasis;
  • Distant metastases;
  • Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
  • Have or are suffering from other malignant tumors;
  • Participating in other clinical trials;
  • Pregnancy or lactation;
  • Have uncontrolled cardiovascular disease;
  • Severe complication, eg, uncontrolled hypertension;
  • Mental disorder;
  • Drug or alcohol addition;
  • Do not have full capacity for civil acts.

Treatment and study plan

Intensity modulated radiation therapy

Radiation

All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).

Other names: IMRT

Chemotherapy

Drug

Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.

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 RTOG/EORTC

  7. Quality of life score

    Time frame: During treatment and 3 years post treatment

    Assessed with EORTC-Quality of life questionnaire-C30 version 3.0

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Chongqing University Cancer Hospital
  • Dongguan People's Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • First Hospital of China Medical University
  • Hubei Cancer Hospital
  • Jiangxi Provincial Cancer Hospital
  • Liuzhou Workers' Hospital
  • The First Affiliated Hospital of Xiamen University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuzhou Red Cross Hospital
  • Zhejiang Cancer Hospital

Registry information

Official study title

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Mar 22, 2023
Registry last updated
May 11, 2026

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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