Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

Detailed Description
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The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

Official Title
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Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy

Conditions
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Nasopharyngeal Cancer

Intervention / Treatment
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* Radiation: Radiotherapy
* Drug: Cisplatin
* Drug: 5-FU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) biopsy-proven carcinoma of the nasopharynx, (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease, (3) normal renal function (Cr < 1.6 mg/dl), Exclusion Criteria: open-neck lymph node biopsy previous chemotherapy or radiotherapy to the head and neck region distant metastasis or other malignant diseases except skin cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCRT alone<br>External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy | Radiation: Radiotherapy<br>* External beam radiotherapy with curative intent, at least 66 Gy<br>Drug: Cisplatin<br>* cisplatin IV injection over 3 hours<br>* Other names: CDDP;Drug: 5-FU<br>* 5-FU IV 24 hours continuous infusion<br>* Other names: 5-fluorouracil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant-metastasis-free survival | percentage of patients who survived and has no distant metastasis | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | percentage of patients who survived | 5 years | 
| disease-free survival | percentage of patients who survived and had no disease recurrence | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant chemotherapy, NPC