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

NCT ID: NCT02610556

Last Updated: 2016-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2022-01-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TP plus IMRT

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

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

Cisplatin 1

Intervention Type: DRUG

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

Intensity-modulated radiotherapy

Intervention Type: RADIATION

Intensity-modulated radiotherapy

DDP plus IMRT

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

Group Type: ACTIVE_COMPARATOR

Cisplatin 2

Intervention Type: DRUG

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

Intensity-modulated radiotherapy

Intervention Type: RADIATION

Intensity-modulated radiotherapy

Interventions

Cisplatin 2

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

Intervention Type: DRUG

Docetaxel

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

Intervention Type: DRUG

Cisplatin 1

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

Intervention Type: DRUG

Intensity-modulated radiotherapy

Intensity-modulated radiotherapy

Intervention Type: RADIATION

Other Intervention Names

DDP; T; P; IMRT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Fang-Yun Xie

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fang-Yun Xie, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fang-Yun Xie, M.D.

Role: CONTACT

xiefy@sysucc.org.cn

+86-020-87342618

Pu-Yun OuYang, M.D.

Role: CONTACT

ouyangpy@sysucc.org.cn

+86-020-87342618

Facility Contacts

Fang-Yun Xie, M.D.

Role: primary

xiefy@sysucc.org.cn

+86-020-87342618

Pu-Yun OuYang, M.D.

Role: backup

ouyangpy@sysucc.org.cn

+86-020-87342618

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2015-FXY-071-Dept. of RT

Identifier Type: -

Identifier Source: org_study_id