Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer

August 21, 2013 updated by: Hospital Authority, Hong Kong

Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma

The objectives of this clinical study are threefold:

To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or PX, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.

Study Overview

Status

Unknown

Conditions

Nasopharyngeal Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

798

Phase

Not Applicable

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
- - Hong Kong, China
    - Queen Elizabeth Hospital
  - Hong Kong, China
    - Prince of Wales Hospital
  - Hong Kong, China
    - Queen Mary Hospital
  - Hong Kong, China
    - Tuen Mun Hospital
  - Hong Kong, China
    - Pamela Youde Nethersole Eastern Hospital
  - Hong Kong, China
    - Princess Margaret Hospital

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically proven nasopharyngeal carcinoma
Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)
Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)
Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.
Liver scan if SGOT exceeds the institutional upper limit of normal
Adequate marrow: WBC > 4 and platelet > 100
Adequate renal function: creatinine clearance > 60 ml/min.
Satisfactory performance status: > 2 by ECOG System.

Exclusion Criteria:

WHO Type I squamous cell carcinoma or adenocarcinoma
Age > 70
Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

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: Factorial Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival Time Frame: 5-year	5-year
Overall Survival Time Frame: 5-year	5-year

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall / Locoregional / Distant Failure Free Rate Time Frame: 5-year	5-year
Chemotherapy and RT toxicity Time Frame: within 90 day from commencement of RT	within 90 day from commencement of RT
Late Toxicity Time Frame: 5-year	5-year

Collaborators and Investigators

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

Sponsor

Hospital Authority, Hong Kong

Collaborators

Hong Kong Nasopharyngeal Cancer Study Group Limited

Investigators

Principal Investigator: Anne WM Lee, Cos, Clinical Oncology, Pamela Youde Nethersole Eastern 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.

Helpful Links

HAREC Clinical Trial Registry

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

September 1, 2006

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria