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Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01872962
Recruitment Status : Unknown
Verified April 2018 by Jun Ma, MD, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
Fudan University
West China Hospital
Tongji Hospital
Peking University
Zhejiang Cancer Hospital
First People's Hospital of Foshan
Cancer Hospital of Guangxi Medical University
Jiangxi Provincial Cancer Hospital
Xijing hospital of The fourth military medical university
Cancer Hospital of Guizhou Province
Affiliated Cancer Hospital of Shantou University Medical College
Fifth Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
Information provided by (Responsible Party):
Jun Ma, MD, Sun Yat-sen University

Study Description
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Brief Summary:
The purpose of this study is to compare induction chemotherapy (gemcitabine+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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: gemcitabine and cisplatin (Induction chemotherapy) Radiation: IMRT and concurrent cisplatin Phase 3

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 2.0-2.30 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study Start Date : November 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: gemcitabine and cisplatin (GP)

Radiation: IMRT and concurrent cisplatin
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 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 2.0-2.30 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.


Outcome Measures
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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


Eligibility Criteria
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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:

  • 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, 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 > 65 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.
Contacts and Locations
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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): NCT01872962


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Fudan University
West China Hospital
Tongji Hospital
Peking University
Zhejiang Cancer Hospital
First People's Hospital of Foshan
Cancer Hospital of Guangxi Medical University
Jiangxi Provincial Cancer Hospital
Xijing hospital of The fourth military medical university
Cancer Hospital of Guizhou Province
Affiliated Cancer Hospital of Shantou University Medical College
Fifth Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
Investigators
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Study Chair: Jun Ma, M.D. Sun Yat-sen University
More Information
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Publications:
Edge SB, Byrd DR, Compton CC, et al: AJCC Cancer Staging Manual (ed 7th). New York, Springer, 2010
Freedman J, Furberg C, DeMets D: Fundamentals of clinical trials. New York, Springer-Verlag, 1998
Chow SC, Shao J, Wang H: Sample Size Calculations in Clinical Research. New York, Marcel Dekker, 2003

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jun Ma, MD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01872962    
Other Study ID Numbers: B2013-022-01
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Keywords provided by Jun Ma, MD, Sun Yat-sen University:
Nasopharyngeal carcinoma
Induction chemotherapy
Concurrent chemoradiotherapy
Clinical trial
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
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action