TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma

April 11, 2023 updated by: XIANG YANQUN, Sun Yat-sen University

TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial

The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in endemic area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, parallel, randomized, open labeled, multicenter phase III clinical trial to compare the survival and toxicity of TPC VS PF as induction chemotherapy combined with CCRT for stage IVa-b nasopharyngeal carcinoma patients in endemic area.The primary endpoint is failure free survival (FFS）.The secondary endpoints are overall survival(OS）,progression-free survival（PFS）, local-regionally relapse free survival(LRFS), distant metastasis free survival（DMFS)and toxicities.

Study Type

Interventional

Enrollment (Actual)

241

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
        • SunYat-senU

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

Description

Inclusion Criteria:

  • WHO II or III pathological type
  • stage Ⅳa or Ⅳb (UICC 7th edition)
  • no anticancer treatment before
  • no malignant history
  • both gender, 18-60 years old
  • enough liver function: TBIL≤ULN；AST/ALT≤2.5×ULN；ALP≤5×ULN
  • enough kidney function: Clcr≥80 mL/min
  • enough hemo: ANC≥2×109/L, PLT≥100×109/L and HB≥9g/dL
  • no sever heart, lung disfunction
  • PS≤2

Exclusion Criteria:

  • previous anticancer treatment
  • distant metastasis
  • pregnant or breasting female
  • can not access to followup
  • enrolled in other therapeutic clinical trial
  • sever infection and internal disease
  • sever disfunction of heart, lung, kidney, liver, etc
  • TBIL>ULN；AST/ALT>2.5×ULN；ALP>5×ULN
  • with factors that will affect the administration, distribution,metabolism or evacuation.
  • using immunosuppressive agents after organ transplantation
  • other malignant history

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: Drug: Taxol,cisplatin and capecitabine
Taxol, cisplatin and capecitabine as induction chemotherapy (IC) combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy |(CCRT).
Other: Drug: Taxol,cisplatin and capecitabine
Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Active Comparator: Drug: Cisplatin and 5-Fluorouracil
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Other: Drug: Cisplatin and 5-Fluorouracil
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival calculated from randomisation to death from any cause
Time Frame: up to 5 years
up to 5 years
Progression free survival calculated from randomisation to disease progression or death from any cause
Time Frame: up to 5 years
up to 5 years
Local-regionally relapse free survival calculated from randomisation to locoregional failure
Time Frame: up to 5 years
up to 5 years
Distant metastasis free survival calculated from randomisation to distant failure
Time Frame: up to 5 years
up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Yanqun Xiang, Sun Yat-sen University
  • Principal Investigator: Taize Yuan, Cancer Center of Guangzhou medical school
  • Principal Investigator: Yunxiang He, Xiangya Hospital

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 (Actual)

October 20, 2016

Primary Completion (Actual)

August 28, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The diagnosis, treatment regimen, toxicity and followup data will be shared once every year through email, phone or meeting.

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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