Effect of Triple Combination of Induction, Concurrent and Adjuvant Chemotherapy in High Risk Nasopharyngeal Carcinoma

NCT02621970 | Unknown Phase 3

• 1 other identifier: 2015-FXY-098-Dept. of RT
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to evaluate the survival benefit from triple combination of induction, concurrent and aduvant chemotherapy versus concurrent chemotherapy alone for high risk locoregionally advanced nasopharyngeal carcinoma treated with intensity-modulated radiotherapy.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• failure-free survival

  Two year

Secondary Outcomes (4)

• overall survival

  two year

• distant metastasis-free survival

  two year

• locoregional relapse-free survival

  two year

• Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0

  two months

Study Arms (2)

IC plus CC plus IMRT plus AC

EXPERIMENTAL

Induction chemotherapy: TP -- Docetaxel 75mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 2 cycles; Concurrent chemotherapy: PX -- Cisplatin 25 mg/m2, D1-3 and Xeloda 2000mg/m2, D1-14, every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy; Adjuvant chemotherapy: Xeloda 2500mg/m2, D1-14, every 3 weeks for 2 cycles

Drug: Cisplatin 1; Drug: Docetaxel; Drug: Xeloda; Radiation: Intensity-modulated radiotherapy

CC plus IMRT

ACTIVE COMPARATOR

Concurrent chemotherapy: Cisplatin 100 mg/m2, D1, every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy

Drug: Cisplatin 2; Radiation: Intensity-modulated radiotherapy

Interventions

Cisplatin 1 DRUG

Cisplatin 25 mg/m2, D1-3

Also known as: DDP

IC plus CC plus IMRT plus AC

Cisplatin 2 DRUG

Cisplatin 100 mg/m2, D1

Also known as: DDP

CC plus IMRT

Docetaxel DRUG

Docetaxel 60mg/m2, D1

Also known as: T

IC plus CC plus IMRT plus AC

Xeloda DRUG

Xeloda 2000mg/m2, D1-14 in concurrent chemotherapy and Xeloda 2500mg/m2, D1-14 in adjuvant chemotherapy

Also known as: X

IC plus CC plus IMRT plus AC

Intensity-modulated radiotherapy RADIATION

Intensity-modulated radiotherapy

Also known as: IMRT

CC plus IMRT; IC plus CC plus IMRT plus AC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
• Tumor staged as T4N0-3M0 or T1-3N3M0 (the 2010 UICC/AJCC staging system).
• Pretreatment EBV DNA ≥ 4000 copies/mL.
• 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.

You may not qualify if:

• 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.
• Dihydropyrimidine dehydrogenase deficiency.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• The First Affiliated Hospital of Guangdong Pharmaceutical University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

• 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.

  PMID: 19064973 BACKGROUND

• 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.

  PMID: 25529384 BACKGROUND

• Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. doi: 10.1016/S1470-2045(11)70320-5. Epub 2011 Dec 7.

  PMID: 22154591 BACKGROUND

• Wu F, Wang R, Lu H, Wei B, Feng G, Li G, Liu M, Yan H, Zhu J, Zhang Y, Hu K. Concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: treatment outcomes of a prospective, multicentric clinical study. Radiother Oncol. 2014 Jul;112(1):106-11. doi: 10.1016/j.radonc.2014.05.005. Epub 2014 Jun 2.

  PMID: 24933452 BACKGROUND

• Zhang LN, Gao YH, Lan XW, Tang J, OuYang PY, Xie FY. Effect of taxanes-based induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: A large scale propensity-matched study. Oral Oncol. 2015 Oct;51(10):950-6. doi: 10.1016/j.oraloncology.2015.07.004. Epub 2015 Jul 21.

  PMID: 26209065 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

SSRP1 protein, human; cisplatin-guanosine adduct; Docetaxel; Capecitabine; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Fang-Yun Xie, M.D.

  Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang-Yun Xie, M.D.

CONTACT

+86-020-87342618; xiefy@sysucc.org.cn

Pu-Yun OuYang, M.D.

CONTACT

+86-020-87342618; ouyangpy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2024
• Last Updated: December 4, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)