Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05304468

Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

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 Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III).
  • Stage II-III（8thAJCC/UICC staging system)
  • Aged 18-70 years
  • ECOG = 0-1
  • HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L
  • ALT,AST<1.5 x ULN；TBIL<1.5×ULN
  • CCR≥60ml/min or Cr<1.5×ULN
  • CR/PR and EBVDNA undetectable after induction chemotherapy
  • Signed informed consent

Exclusion criteria

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma
  • Age <18 or >70years
  • Treatment with palliative intent
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
  • Pregnancy or lactation
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume)
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance

Treatment and study plan

IMRT

Radiation

Patients in experimental group received reduced dose IMRT

Induction chemotherapy

Drug

cisplatin-based induction chemotherapy for two cycles

cisplatin concurrent chemotherapy

Drug

cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)

Primary outcomes

  1. PFS (progression-free survival)

    Time frame: 2 year

    Defined as the time from randomization to documented disease recurrence (either distant metastasis or locoregional disease recurrence) or death from any cause, whichever occurred first.

Secondary outcomes

  1. Overall Survival(OS)

    Time frame: 2 year

    Defined as the time from randomization to death from any cause

  2. Locoregional relapse-free survival(LRFS)

    Time frame: 2 year

    Defined as the time from randomization to the first local or regional recurrence, or death from any cause.

    follow-up visit.

  3. Distant metastasis-free survival(DMFS)

    Time frame: 2 year

    Defined as the time from randomization to the first distant metastasis or death from any cause.

  4. Overall response rate

    Time frame: 3 months

    Tumour response rate was classified according to RECIST, version 1.1

  5. Incidence rate of adverse events (AEs)

    Time frame: 2 year

    Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

  6. Change of QoL

    Time frame: 1 year

    QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy

  7. Change of EORTC quality of life questionnaire(QLQ) Head and Neck score

    Time frame: 1 year

    QoL scores were assessed by using EORTC quality of life questionnaire(QLQ) Head and Neck. The QLQ-H&N35 is composed of seven multi-item symptom scales (pain, swallowing, sensation, speech, eating from a social,perspective, social interactions, and sexuality) and 11 single-item symptom scales (teeth, opening mouth,dry mouth, sticky saliva,coughing, felt ill, pain medication use, nutritional supplementation, feeding tube requirement, weight loss, and weight gain). All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems.All of the scores mentioned above were assessed at the below time point:before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Phase III Randomized Non-inferiority Trial of Reduced-dose Versus Standard Dose Radiotherapy for Stage II-III Nasopharyngeal Carcinoma Which Have Favorable Response After Induction Chemotherapy

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
Mar 31, 2022
Registry last updated
Mar 21, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.