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Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With IMRT in High Risk Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cisplatin 2

Docetaxel

Cisplatin 1

Intensity-modulated radiotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring NPC, concurrent chemotherapy, docetaxel, cisplatin

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 T1N3M0, T2-3N2-3M0 or T4N0-3M0 (the 2010 UICC/AJCC staging system).
Pretreatment EBV DNA ≥ 1500 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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TP plus IMRT

DDP plus IMRT

Arm Description

Concurrent chemotherapy: TP - Docetaxel 60mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy

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

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

failure-free 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

NCT02610556

First Posted

November 13, 2015

Last Updated

May 25, 2016

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

NCT02610556

Brief Title

Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With IMRT in High Risk Nasopharyngeal Carcinoma

Official Title

Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With Intensity-modulated Radiotherapy in High Risk Locregionally Advanced Nasopharyngeal Carcinoma: a Phase 2 Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

January 2022 (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 efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma.

Detailed Description

Eligible patients are randomly assigned to receive intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy of docetaxel plus cisplatin or cisplatin alone. IMRT is delivered with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Concurrent chemotherapy in the experimental arm consists of docetaxel 60 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 3 cycles. Concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is overall survival (OS), defined as time from randomization to the day of death from any cause. Secondary end points include failure-free survival (FFS), 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

NPC, concurrent chemotherapy, docetaxel, cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TP plus IMRT

Arm Type

Experimental

Arm Description

Concurrent chemotherapy: TP - Docetaxel 60mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy

Arm Title

DDP plus IMRT

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin 2

Other Intervention Name(s)

DDP

Intervention Description

Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Intervention Description

Docetaxel 60 mg/m2, D1 every 3 weeks for 3 cycles

Intervention Type

Drug

Intervention Name(s)

Cisplatin 1

Other Intervention Name(s)

Intervention Description

Cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiotherapy

Other Intervention Name(s)

IMRT

Intervention Description

Intensity-modulated radiotherapy

Primary Outcome Measure Information:

Title

overall survival

Time Frame

two year

Secondary Outcome Measure Information:

Title

failure-free 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

up to two months

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 T1N3M0, T2-3N2-3M0 or T4N0-3M0 (the 2010 UICC/AJCC staging system). Pretreatment EBV DNA ≥ 1500 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.

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fang-Yun Xie, M.D.

Phone

+86-020-87342618

xiefy@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Pu-Yun OuYang, M.D.

Phone

+86-020-87342618

ouyangpy@sysucc.org.cn

12. IPD Sharing Statement

Citations:

PubMed Identifier

26209065

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.

Results Reference

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PubMed Identifier

19619443

Citation

Xie FY, Zou GR, Hu WH, Qi SN, Peng M, Li JS. [Induction chemotherapy with docetaxel plus cisplatin (TP regimen) followed by concurrent chemoradiotherapy with TP regimen versus cisplatin in treating locally advanced nasopharyngeal carcinoma]. Ai Zheng. 2009 Mar;28(3):279-85. Chinese.

Results Reference

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PubMed Identifier

1346533

Citation

Tishler RB, Schiff PB, Geard CR, Hall EJ. Taxol: a novel radiation sensitizer. Int J Radiat Oncol Biol Phys. 1992;22(3):613-7. doi: 10.1016/0360-3016(92)90888-o.

Results Reference

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PubMed Identifier

1350755

Citation

Tishler RB, Geard CR, Hall EJ, Schiff PB. Taxol sensitizes human astrocytoma cells to radiation. Cancer Res. 1992 Jun 15;52(12):3495-7.

Results Reference

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PubMed Identifier

24688084

Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With IMRT in High Risk Nasopharyngeal Carcinoma

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