A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

May 26, 2014 updated by: Hong Ming-huang, Sun Yat-sen University

A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of locoregionally advanced NPC with high-risk metastasis.

In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

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
        • Recruiting
        • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Minghuang Hong, MD

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO II or III
  • Original clinical stage must be T4 or N2-3 （UICC 2002）
  • Male and no pregnant female
  • Age between 18-60
  • WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3
  • With normal liver function test (ALT、AST≤2.5×ULN)
  • With normal renal function test (Creatinine ≤ 1.5×ULN)
  • Performance status scale ECOG grade 0，1
  • Without radiotherapy or chemotherapy
  • Patients must give signed informed consent

Exclusion Criteria:

  • Patients have evidence of relapse or distant metastasis
  • The presence of uncontrolled life-threatening illness
  • Receiving other ways of anti-cancer therapy
  • Receiving radiotherapy or chemotherapy
  • Investigator consider the patients can't finish the whole study

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy
Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
Other Names:
  • Neoadjuvant Chemotherapy Followed by CCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
distant metastasis free survival,disease free survival
Time Frame: 5-Yr
5-Yr

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5-Yr
5-Yr

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

Guangdong Provincial People's Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Investigators

  • Study Chair: Minghuang Hong, MD, Sun Yet sen Cancer Center, China

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, 2008

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007047

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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