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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02973386
Other study ID # CCRT-AC-HRDM-NPC
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 2017
Est. completion date December 2025

Study information

Verified date May 2024
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 278
Est. completion date December 2025
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IMRT combine with cisplatin concurrent chemotherapy
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
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.

Locations

Country Name City State
China Cancer Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Distant metastasis-free survival Defined as the time from date of recruitment to documented distant metastasis or death from any cause. Five year
Secondary Failure-free survival Defined as the time from date of recruitment to documented relapse or death from any cause. Five year
Secondary Locoregional relapse-free survival Defined as the time from date of recruitment to documented locoregional relapse or death from any cause. Five year
Secondary Overall survival Defined as the time from date of recruitment to death from any cause. Five year
Secondary Acute toxicity 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. three months after corresponding treatment
Secondary Late toxicity Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria. Five year
See also
  Status Clinical Trial Phase
Completed NCT02143388 - Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial Phase 3