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

Induction Chemotherapy of Docetaxel, Cisplatin and Xeloda in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma

Sponsors

Lead Sponsor: Sun Yat-sen University

Source Sun Yat-sen University
Brief 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.

Detailed Description

All eligible patients receive intensity-modulated radiotherapy (IMRT) with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Nomogram-predicted low risk patients (Group A) receive concurrent chemotherapy, while nomogram-predicted high risk patients are randomized to receive concurrent chemotherapy (Group B) or induction chemotherapy followed by concurrent chemotherapy (Group C). Induction chemotherapy consists of docetaxel 65 mg/m², D1, cisplatin 75 mg/m², D1 and Xeloda 2000mg/m², D1-14 every 3 weeks for 3 cycles. Concurrent chemotherapy consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Overall Status Not yet recruiting
Start Date August 2016
Completion Date August 2021
Primary Completion Date August 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
FFS 2 years
Enrollment 235
Condition
Intervention

Intervention Type: Drug

Intervention Name: Docetaxel

Description: Docetaxel 65mg/m2 in induction chemotherapy

Arm Group Label: Group C

Other Name: T

Intervention Type: Drug

Intervention Name: Cisplatin 1

Description: Cisplatin 75mg/m2 in induction chemotherapy

Arm Group Label: Group C

Other Name: P

Intervention Type: Drug

Intervention Name: Xeloda

Description: Xeloda 2000mg/m2 D1-14 in induction chemotherapy

Arm Group Label: Group C

Other Name: X

Intervention Type: Radiation

Intervention Name: IMRT

Description: IMRT for all patients

Intervention Type: Drug

Intervention Name: Cisplatin 2

Description: Cisplatin 100mg/m2 in concurrent chemotherapy

Other Name: DDP

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Contact

Last Name: Fang-Yun Xie

Phone: +8602087342618

Email: [email protected]

Location
Facility: Sun Yat-sen University Cancer Center
Location Countries

China

Verification Date

May 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Sun Yat-sen University

Investigator Full Name: Fang-Yun Xie

Investigator Title: Prof.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Group A

Type: Active Comparator

Description: low risk NPC treated with concurrent chemoradiotherapy

Label: Group B

Type: Active Comparator

Description: high risk NPC treated with concurrent chemoradiotherapy

Label: Group C

Type: Experimental

Description: high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov