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

Primary Purpose

Local Advanced High Risk Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IMRT combine with cisplatin concurrent chemotherapy
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Local Advanced High Risk Nasopharyngeal Carcinoma focused on measuring Local advanced, High Risk, Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent chemoradiation + adjuvant chemotherapy

Concurrent chemoradiation

Arm Description

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

IMRT combine with cisplatin concurrent chemotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Failure-free survival
Defined as the time from date of recruitment to documented relapse or death from any cause.
Locoregional relapse-free survival
Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.
Overall survival
Defined as the time from date of recruitment to death from any cause.
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.
Late toxicity
Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.

Full Information

First Posted
November 22, 2016
Last Updated
April 9, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02973386
Brief Title
Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Local Advanced High Risk Nasopharyngeal Carcinoma
Keywords
Local advanced, High Risk, Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent chemoradiation + adjuvant chemotherapy
Arm Type
Experimental
Arm Description
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Arm Title
Concurrent chemoradiation
Arm Type
Active Comparator
Arm Description
IMRT combine with cisplatin concurrent chemotherapy
Intervention Type
Drug
Intervention Name(s)
IMRT combine with cisplatin concurrent chemotherapy
Intervention Description
Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.
Intervention Type
Drug
Intervention Name(s)
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Intervention Description
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 Outcome Measure Information:
Title
Distant metastasis-free survival
Description
Defined as the time from date of recruitment to documented distant metastasis or death from any cause.
Time Frame
Five year
Secondary Outcome Measure Information:
Title
Failure-free survival
Description
Defined as the time from date of recruitment to documented relapse or death from any cause.
Time Frame
Five year
Title
Locoregional relapse-free survival
Description
Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.
Time Frame
Five year
Title
Overall survival
Description
Defined as the time from date of recruitment to death from any cause.
Time Frame
Five year
Title
Acute toxicity
Description
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.
Time Frame
three months after corresponding treatment
Title
Late toxicity
Description
Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.
Time Frame
Five year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
miao jingjing
Phone
+86-13631355201
Email
miaojj@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
wu haijun
Phone
+86-18819200847
Email
wuhj@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhao chong, M.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao chong, M.D
Phone
+86-13902206160
Email
zhaochong@sysucc.org.cn

12. IPD Sharing Statement

Links:
URL
http://www.sysucc.org.cn
Description
Home Page of Cancer Center, Sun Yat-sen University

Learn more about this trial

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

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