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

Not Applicable

• Conditions: Nasopharyngeal Neoplasms

• Registration Number: NCT00577057
• Lead Sponsor: Hospital Authority, Hong Kong

Brief Summary

The objectives of this clinical study are threefold:

1. 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.

2. 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.

3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-21
• Last Update Posted: 2013-08-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 798

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Progression-free survival	5-year
Overall Survival	5-year

Secondary Outcome Measures

Name	Time	Method
Overall / Locoregional / Distant Failure Free Rate	5-year
Chemotherapy and RT toxicity	within 90 day from commencement of RT
Late Toxicity	5-year

Trial Locations

Locations (6)

Tuen Mun Hospital; 🇨🇳 Hong Kong, China

Prince of Wales Hospital; 🇨🇳 Hong Kong, China

Pamela Youde Nethersole Eastern Hospital; 🇨🇳 Hong Kong, China

Princess Margaret Hospital; 🇨🇳 Hong Kong, China

Queen Elizabeth Hospital; 🇨🇳 Hong Kong, China

Queen Mary Hospital; 🇨🇳 Hong Kong, China