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

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ClinicalTrials.gov Identifier: NCT02610556
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : May 26, 2016
Sponsor:
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
Information provided by (Responsible Party):
Fang-Yun Xie, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Cisplatin 2 Drug: Docetaxel Drug: Cisplatin 1 Radiation: Intensity-modulated radiotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Docetaxel
Docetaxel 60 mg/m2, D1 every 3 weeks for 3 cycles
Other Name: T

Drug: Cisplatin 1
Cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles
Other Name: P

Radiation: Intensity-modulated radiotherapy
Intensity-modulated radiotherapy
Other Name: IMRT

Active Comparator: DDP plus IMRT
Concurrent chemotherapy: DDP - Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy
Drug: Cisplatin 2
Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles
Other Name: DDP

Radiation: Intensity-modulated radiotherapy
Intensity-modulated radiotherapy
Other Name: IMRT




Primary Outcome Measures :
  1. overall survival [ Time Frame: two year ]

Secondary Outcome Measures :
  1. failure-free survival [ Time Frame: two year ]
  2. distant metastasis-free survival [ Time Frame: two year ]
  3. locoregional relapse-free survival [ Time Frame: two year ]
  4. Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0 [ Time Frame: up to two months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610556


Contacts
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Contact: Fang-Yun Xie, M.D. +86-020-87342618 xiefy@sysucc.org.cn
Contact: Pu-Yun OuYang, M.D. +86-020-87342618 ouyangpy@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Fang-Yun Xie, M.D.    +86-020-87342618    xiefy@sysucc.org.cn   
Contact: Pu-Yun OuYang, M.D.    +86-020-87342618    ouyangpy@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Investigators
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Principal Investigator: Fang-Yun Xie, M.D. Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China

Publications:

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Responsible Party: Fang-Yun Xie, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02610556     History of Changes
Other Study ID Numbers: 2015-FXY-071-Dept. of RT
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Keywords provided by Fang-Yun Xie, Sun Yat-sen University:
NPC
concurrent chemotherapy
docetaxel
cisplatin
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal 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
Cisplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action