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

Hospital Authority, Hong Kong6 sites in 1 country798 target enrollmentSeptember 2006

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

August 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Sponsor

Hospital Authority, Hong Kong

•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.

•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.