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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Not yet recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Cisplatin 1

Cisplatin 2

Docetaxel

Xeloda

Intensity-modulated radiotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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.
Dihydropyrimidine dehydrogenase deficiency.

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IC plus CC plus IMRT plus AC

CC plus IMRT

Arm Description

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

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

Outcomes

Primary Outcome Measures

failure-free survival

Secondary Outcome Measures

overall survival

distant metastasis-free survival

locoregional relapse-free survival

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

Full Information

NCT ID

NCT02621970

First Posted

December 2, 2015

Last Updated

December 2, 2015

Sponsor

Sun Yat-sen University

Collaborators

Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University

1. Study Identification

Unique Protocol Identification Number

NCT02621970

Brief Title

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

Official Title

Randomized Phase 3 Trial of Triple Combination of Induction, Concurrent and Adjuvant Chemotherapy Versus Concurrent Chemotherapy Alone in High Risk Nasopharyngeal Carcinoma Patients Treated With Intensity-modulated Radiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

All eligible patients receive intensity-modulated radiotherapy (IMRT) with a total dose of 68 to 70 Gy in 33 fractions to the primary tumor. Patients in the experimental arm receive triple therapy of induction, concurrent and adjuvant chemotherapy. Induction chemotherapy consists of docetaxel 75 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 2 cycles. Concurrent chemotherapy in the experimental arm consists of cisplatin 25 mg/m², D1-3 every 3 weeks and Xeloda 2000mg/m², D1-14 for 3 cycles. Adjuvant chemotherapy consists of Xeloda 2500mg/m², D1-14 for 2 cycles. Concurrent chemotherapy in the control arm 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

534 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IC plus CC plus IMRT plus AC

Arm Type

Experimental

Arm Description

Arm Title

CC plus IMRT

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin 1

Other Intervention Name(s)

DDP

Intervention Description

Cisplatin 25 mg/m2, D1-3

Intervention Type

Drug

Intervention Name(s)

Cisplatin 2

Other Intervention Name(s)

DDP

Intervention Description

Cisplatin 100 mg/m2, D1

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Intervention Description

Docetaxel 60mg/m2, D1

Intervention Type

Drug

Intervention Name(s)

Xeloda

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiotherapy

Other Intervention Name(s)

IMRT

Intervention Description

Intensity-modulated radiotherapy

Primary Outcome Measure Information:

Title

failure-free survival

Time Frame

Two year

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

two year

Title

distant metastasis-free survival

Time Frame

two year

Title

locoregional relapse-free survival

Time Frame

two year

Title

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

Time Frame

two months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Dihydropyrimidine dehydrogenase deficiency.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fang-Yun Xie, M.D.

Phone

+86-020-87342618

xiefy@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Pu-Yun OuYang, M.D.

Phone

+86-020-87342618

ouyangpy@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fang-Yun Xie, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19064973

Citation

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.

Results Reference

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PubMed Identifier

25529384

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. Erratum In: Cancer. 2020 Jan 15;126(2):454-455.

Results Reference

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PubMed Identifier

22154591

Citation

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.

Results Reference

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PubMed Identifier

24933452

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

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

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