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

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ClinicalTrials.gov Identifier: NCT02786641
Recruitment Status : Not yet recruiting
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Fang-Yun Xie, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Docetaxel Drug: Cisplatin 1 Drug: Xeloda Radiation: IMRT Drug: Cisplatin 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Chemotherapy of Docetaxel, Cisplatin and Xeloda in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Active Comparator: Group A
low risk NPC treated with concurrent chemoradiotherapy
Radiation: IMRT
IMRT for all patients

Drug: Cisplatin 2
Cisplatin 100mg/m2 in concurrent chemotherapy
Other Name: DDP

Active Comparator: Group B
high risk NPC treated with concurrent chemoradiotherapy
Radiation: IMRT
IMRT for all patients

Drug: Cisplatin 2
Cisplatin 100mg/m2 in concurrent chemotherapy
Other Name: DDP

Experimental: Group C
high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
Drug: Docetaxel
Docetaxel 65mg/m2 in induction chemotherapy
Other Name: T

Drug: Cisplatin 1
Cisplatin 75mg/m2 in induction chemotherapy
Other Name: P

Drug: Xeloda
Xeloda 2000mg/m2 D1-14 in induction chemotherapy
Other Name: X

Radiation: IMRT
IMRT for all patients

Drug: Cisplatin 2
Cisplatin 100mg/m2 in concurrent chemotherapy
Other Name: DDP




Primary Outcome Measures :
  1. FFS [ Time Frame: 2 years ]


Information from the National Library of Medicine

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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 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

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): NCT02786641


Contacts
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Contact: Fang-Yun Xie +8602087342618 xiefy@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University

Publications:
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Responsible Party: Fang-Yun Xie, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02786641     History of Changes
Other Study ID Numbers: 2016-FXY-012-Dept. of RT
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fang-Yun Xie, Sun Yat-sen University:
nasopharyngeal carcinoma
induction chemotherapy
concurrent chemotherapy
docetaxel
cisplatin
xeloda
nomogram
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
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites