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History of Changes for Study: NCT01872962
Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Latest version (submitted April 20, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 6, 2013 None (earliest Version on record)
2 November 6, 2013 Study Status, Eligibility, Sponsor/Collaborators, Study Description, Arms and Interventions and Study Identification
3 March 16, 2014 Recruitment Status, Study Status and Contacts/Locations
4 February 19, 2017 Recruitment Status, Study Status, Contacts/Locations, Study Design and Sponsor/Collaborators
5 April 20, 2018 Recruitment Status and Study Status
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Study NCT01872962
Submitted Date:  June 6, 2013 (v1)
Open or close this module Study Identification
Unique Protocol ID: B2013-015-01
Brief Title: Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title: Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2013
Overall Status: Not yet recruiting
Study Start: July 2013
Primary Completion: July 2018 [Anticipated]
Study Completion: July 2020 [Anticipated]
First Submitted: May 31, 2013
First Submitted that
Met QC Criteria:		 June 6, 2013
First Posted: June 7, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:		 June 6, 2013
Last Update Posted: June 7, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sun Yat-sen University
Responsible Party: Principal Investigator
Investigator: Jun Ma
Official Title: Professor
Affiliation: Sun Yat-sen University
Collaborators: Fudan University
West China Hospital
Tongji Hospital
Peking University
Zhejiang Cancer Hospital
First People's Hospital of Foshan
Guangxi Medical University
Jiangxi Provincial Cancer Hospital
Air Force Military Medical University, China
The First Affiliated Hospital of Nanchang University
Cancer Hospital of Guizhou Province
Affiliated Cancer Hospital of Shantou University Medical College
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to compare induction chemotherapy (gemcitabin+cisplatin) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in NPC patients.
Detailed Description: Patients Patients with non-keratinizing NPC T3-4N1M0/TxN2-3M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy plus CCRT or CCRT alone. Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.0-2.27 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. The induction chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Open or close this module Conditions
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Induction chemotherapy
Concurrent chemoradiotherapy
Clinical trial
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 476 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Induction chemotherapy+IMRT and concurrent cisplatin
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
 Drug: gemcitabine and cisplatin (Induction chemotherapy)
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
Other Names:
  • gemcitabine and cisplatin (GP)
Radiation: IMRT and concurrent cisplatin
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.27 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
Active Comparator: IMRT and concurrent cisplatin
Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
 Radiation: IMRT and concurrent cisplatin
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.27 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Failure-free survival
[ Time Frame: 3-year ]

Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
Secondary Outcome Measures:
1. Overall survival
[ Time Frame: 3-year ]

Overall survival is calculated from randomization to death from any cause.
2. Locoregional failure-free survival
[ Time Frame: 3-year ]

Locoregional failure-free survival is calculated from randomization to the first locoregional failure.
3. Distant failure-free survival
[ Time Frame: 3-year ]

Distant failure-free survival is calculated from randomization to the first remote failure.
4. Number of participants with adverse events
[ Time Frame: up to 3 years ]

Incidence of acute and late toxicity
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 59 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
  • Tumor staged as T3-4N1/N2-3 (according to the 7th AJCC edition).
  • No evidence of distant metastasis (M0).
  • Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
  • Adequate marrow: leucocyte count ≥ 4000/μL, neutrophil count ≥ 2000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
  • Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN.
  • Adequate renal function: creatinine clearance ≥ 60 ml/min.
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age ≥ 60 or < 18.
  • Treatment with palliative intent.
  • 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 RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior 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.
Open or close this module Contacts/Locations
Central Contact Person: Jun Ma, M. D.
Telephone: +86-20-87343469
Email: majun2@mail.sysu.edu.cn
Study Officials: Jun Ma, M.D.
Study Chair
Sun Yat-sen University
Locations: China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Contact:Contact: Jun Ma, M.D. +86-20-87343469 majun2@mail.sysu.edu.cn
Open or close this module IPDSharing
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Open or close this module References
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