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

Local Advanced High Risk Nasopharyngeal Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02973386
• Other study ID #: CCRT-AC-HRDM-NPC
• Status: Active, not recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Local Advanced High Risk Nasopharyngeal Carcinoma
• Nasopharyngeal Carcinoma

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

External Links

•   Home Page of Cancer Center, Sun Yat-sen University