Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Beijing Cancer Hospital; Fifth Affiliated Hospital, Sun Yat-Sen University; Fudan University; Guangdong General Hospital; Guangdong Provincial People's Hospital; Huazhong University of Science and Technology; Zhejiang Cancer Hospital
• Treatments: Cisplatin; Fluorouracil

Criteria

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)

2. Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)

3. No evidence of distant metastasis (M0)

4. Performance status: KPS ≥70

5. With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)

6. Renal: creatinine clearance ≥60ml/min

7. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL

8. Written informed consent

Exclusion Criteria:

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

2. Age ≥70 or <18

3. With a history of renal disease

4. Prior malignancy

5. Previous chemotherapy or radiotherapy

6. Patient is pregnant or lactating

7. Unstable cardiac disease requiring treatment.

8. Emotion disturbance