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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nasopharyngeal Neoplasms

Intervention / Treatment
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* Procedure: Conventional Radiotherapy
* Procedure: Accelerated Radiotherapy
* Drug: Cisplatin
* Drug: 5-fluorouracil
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Conventional Radiotherapy|nan|
|Procedure: Accelerated Radiotherapy|nan|
|Drug: Cisplatin|nan|
|Drug: 5-fluorouracil|nan|
|Drug: Capecitabine|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage III - IVB, Nasopharyngeal Carcinoma