Skip to main content
OpenTrials
Completed

NCT Number: NCT02973386

Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Local Advanced High Risk Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma 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

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

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 carcinoma(WHO II/III)
  • Clinical stage III~IVb(UICC/AJCC 7th)
  • No distant metastasis
  • Karnofsky Performance Status Scale≥70
  • WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L
  • ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
  • Sign the informed consent.

Exclusion criteria

  • Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
  • Younger than 18 years old or older than 70 years old
  • Are receiving other drugs treanment
  • kidney disease
  • Have suffered from other tumor or now suffering from other tumor
  • Have recieved chemotherapy or radiotherapy
  • Pregnancy or lactation
  • unstable heart disease need timely treatment
  • Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes

Treatment and study plan

IMRT combine with cisplatin concurrent chemotherapy

Drug

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Drug

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.

Primary outcomes

  1. Distant metastasis-free survival

    Time frame: Five year

    Defined as the time from date of recruitment to documented distant metastasis or death from any cause.

Secondary outcomes

  1. Failure-free survival

    Time frame: Five year

    Defined as the time from date of recruitment to documented relapse or death from any cause.

  2. Locoregional relapse-free survival

    Time frame: Five year

    Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.

  3. Overall survival

    Time frame: Five year

    Defined as the time from date of recruitment to death from any cause.

  4. Acute toxicity

    Time frame: three months after corresponding treatment

    Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.

  5. Late toxicity

    Time frame: Five year

    Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis

Important dates

Study start
2017
Primary completion
2022
Study completion
2025
First posted
Nov 25, 2016
Registry last updated
May 7, 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.

Related clinical trials

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