Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

July 11, 2013 updated by: Sun Yat-sen University

A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.

Study Type

Interventional

Enrollment (Anticipated)

506

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
  2. Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
  3. No evidence of distant metastasis (M0)
  4. Performance status: KPS ≥70
  5. With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
  6. Renal: creatinine clearance ≥60ml/min
  7. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
  8. Written informed consent

Exclusion Criteria:

  1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  2. Age ≥70 or <18
  3. With a history of renal disease
  4. Prior malignancy
  5. Previous chemotherapy or radiotherapy
  6. Patient is pregnant or lactating
  7. Unstable cardiac disease requiring treatment.
  8. Emotion disturbance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Concurrent and adjuvant
Concurrent chemoradiotherapy plus adjuvant chemotherapy
Drug: Cisplatin,fluorouracil
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.
Other Names:
  • Cisplatin and fluorouracil
ACTIVE_COMPARATOR: Concurrent
Concurrent chemoradiotherapy
Drug: Cisplatin
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure-free survival
Time Frame: 2-yr
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
2-yr

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival, distant failure-free survival and locoregional failure-free survival
Time Frame: 2-yr
Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded.
2-yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Zhejiang Cancer Hospital
Fudan University
Peking University Cancer Hospital & Institute
Huazhong University of Science and Technology
Guangdong Provincial People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (ESTIMATE)

May 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 12, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YP2008004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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