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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Docetaxel

Cisplatin 1

Xeloda

IMRT

Cisplatin 2

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring nasopharyngeal carcinoma, induction chemotherapy, concurrent chemotherapy, docetaxel, cisplatin, xeloda, nomogram

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

low risk NPC treated with concurrent chemoradiotherapy

high risk NPC treated with concurrent chemoradiotherapy

high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy

Outcomes

Primary Outcome Measures

FFS

Secondary Outcome Measures

Full Information

NCT ID

NCT02786641

First Posted

May 26, 2016

Last Updated

May 26, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02786641

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

August 2018 (Anticipated)

Study Completion Date

August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma, induction chemotherapy, concurrent chemotherapy, docetaxel, cisplatin, xeloda, nomogram

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

235 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

low risk NPC treated with concurrent chemoradiotherapy

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

high risk NPC treated with concurrent chemoradiotherapy

Arm Title

Group C

Arm Type

Experimental

Arm Description

high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Intervention Description

Docetaxel 65mg/m2 in induction chemotherapy

Intervention Type

Drug

Intervention Name(s)

Cisplatin 1

Other Intervention Name(s)

Intervention Description

Cisplatin 75mg/m2 in induction chemotherapy

Intervention Type

Drug

Intervention Name(s)

Xeloda

Other Intervention Name(s)

Intervention Description

Xeloda 2000mg/m2 D1-14 in induction chemotherapy

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

IMRT for all patients

Intervention Type

Drug

Intervention Name(s)

Cisplatin 2

Other Intervention Name(s)

DDP

Intervention Description

Cisplatin 100mg/m2 in concurrent chemotherapy

Primary Outcome Measure Information:

Title

FFS

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

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

Fang-Yun Xie

Phone

+8602087342618

xiefy@sysucc.org.cn

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

Undecided

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

background

PubMed Identifier

26467665

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):djv291. doi: 10.1093/jnci/djv291. Print 2016 Jan.

Results Reference

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

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