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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02786641
• Other study ID #: 2016-FXY-012-Dept. of RT
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 26, 2016
• Last updated: May 26, 2016
• Start date: August 2016
• Est. completion date: August 2021

Study information

• Verified date: May 2016
• Source: Sun Yat-sen University
• Contact: Fang-Yun Xie
• Phone: +8602087342618
• Email: xiefy[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 235
• Est. completion date: August 2021
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel 65mg/m2 in induction chemotherapy
• Cisplatin 1
Cisplatin 75mg/m2 in induction chemotherapy
• Xeloda
Xeloda 2000mg/m2 D1-14 in induction chemotherapy

Radiation:
• IMRT
IMRT for all patients

Drug:
• Cisplatin 2
Cisplatin 100mg/m2 in concurrent chemotherapy

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Hui EP, Ma BB, Leung SF, King AD, Mo F, Kam MK, Yu BK, Chiu SK, Kwan WH, Ho R, Chan I, Ahuja AT, Zee BC, Chan AT. Randomized phase II trial of concurrent cisplatin-radiotherapy with or without neoadjuvant docetaxel and cisplatin in advanced nasopharyngeal carcinoma. J Clin Oncol. 2009 Jan 10;27(2):242-9. doi: 10.1200/JCO.2008.18.1545. Epub 2008 Dec 8. — View Citation

Lee AW, Ngan RK, Tung SY, Cheng A, Kwong DL, Lu TX, Chan AT, Chan LL, Yiu H, Ng WT, Wong F, Yuen KT, Yau S, Cheung FY, Chan OS, Choi H, Chappell R. Preliminary results of trial NPC-0501 evaluating the therapeutic gain by changing from concurrent-adjuvant to induction-concurrent chemoradiotherapy, changing from fluorouracil to capecitabine, and changing from conventional to accelerated radiotherapy fractionation in patients with locoregionally advanced nasopharyngeal carcinoma. Cancer. 2015 Apr 15;121(8):1328-38. doi: 10.1002/cncr.29208. Epub 2014 Dec 19. — View Citation

Tang LQ, Li CF, Li J, Chen WH, Chen QY, Yuan LX, Lai XP, He Y, Xu YX, Hu DP, Wen SH, Peng YT, Zhang L, Guo SS, Liu LT, Guo L, Wu YS, Luo DH, Huang PY, Mo HY, Xiang YQ, Sun R, Chen MY, Hua YJ, Lv X, Wang L, Zhao C, Cao KJ, Qian CN, Guo X, Zeng YX, Mai HQ, Zeng MS. Establishment and Validation of Prognostic Nomograms for Endemic Nasopharyngeal Carcinoma. J Natl Cancer Inst. 2015 Oct 14;108(1). pii: djv291. doi: 10.1093/jnci/djv291. Print 2016 Jan. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFS		2 years	Yes