Overview

Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

Status:
Unknown status
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
Summary
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang Cancer Hospital
Collaborators:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Wenzhou Medical University
Zhejiang Provincial People's Hospital
Zhejiang Provincial People’s Hospital
Zhejiang University
Treatments:
Cisplatin
Docetaxel
Fluorouracil
Criteria
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.

2. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system)

3. No evidence of distant metastasis(M0)

4. Performance status:KPS>70

5. With normal liver function test(ALT, AST<1.5ULN)

6. Renal:creatinine clearance >60ml/min

7. Without hematopathy,marrow:WBC>4*109/L, HGB>80G/L, and PLT>100*109/L.

8. With controled blood glucose for diabetes patients

9. Written informed consent

Exclusion Criteria:

1. WHO type I squamous cell carcinoma or adenocarcinoma

2. Age>70 or <18

3. With a history of renal disease

4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or
basal/squamous cell carcinoma of the skin0

5. Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the
intended RT treatment volume)

6. Patient is pregnant or lactating .

7. Peripheral neuropathy

8. Emotional disturbance