Overview

Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma

Status:
Unknown status
Trial end date:
2021-08-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators aim to evaluate the efficiency and toxicities of induction chemotherapy of docetaxel, cisplatin and xeloda in nomogram-predicted high risk locoregionally advanced nasopharyngeal carcinoma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Capecitabine
Cisplatin
Docetaxel
Criteria
Inclusion Criteria:

- Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.

- Tumor staged as III-IVb (the 2010 UICC/AJCC staging system).

- Karnofsky scale (KPS) ≥ 70.

- Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥
100×10E9/L.

- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase
(AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline
phosphatase (ALP) ≤ 2.5×ULN.

- Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.

- Patients must give written informed consent.

Exclusion Criteria:

- Prior malignancy, except adequately treated basal cell or squamous cell skin cancer,
in situ cervical cancer.

- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and
emphasize effective contraception during the treatment period).

- History of previous radiotherapy (except for non-melanomatous skin cancers outside
intended radiotherapy volume).

- Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or
nodes.

- Any severe intercurrent disease, which may bring unacceptable risk or affect the
compliance of the trial, for example, unstable cardiac disease requiring treatment,
renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >
1.5×ULN), and emotional disturbance.

- Deficient in dihydropyrimidine dehydrogenase