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

Hospital Authority, Hong Kong

Status

Unknown

Conditions

Nasopharyngeal Neoplasms

Treatments

Drug: 5-fluorouracil

Procedure: Accelerated Radiotherapy

Drug: Capecitabine

Drug: Cisplatin

Procedure: Conventional Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

HKEC-2006-120

HARECCTR0500062

NPC-0501

Details and patient eligibility

About

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.

Enrollment

798 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.