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Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC (NPC)

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: NCT01854203
Recruitment Status : Unknown
Verified July 2013 by Jian-jun Li, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 15, 2013
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Jian-jun Li, Sun Yat-sen University

Study Description
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Brief Summary:
Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Inductive chemotherapy + concurrent cisplatin and IMRT Drug: Inductive chemotherapy + IMRT Phase 2 Phase 3

Detailed Description:
The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma
Study Start Date : July 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IInductive chemotherapy + concurrent cisplatin and IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.
 Drug: Inductive chemotherapy + concurrent cisplatin and IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.
Other Name: Gemcitabine and cisplatin
Experimental: Inductive chemotherapy + IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
 Drug: Inductive chemotherapy + IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
Other Name: Gemcitabine and cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3-year ]
    Overall survival is calculated from randomization to death from any cause.

  2. Failure-free survival [ Time Frame: 3-year ]
    Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

  3. Locoregional failure-free survival [ Time Frame: 3-year ]
    the latency to the first local failure

  4. Distant failure-free survival [ Time Frame: 3-year ]
    The latency to the first remote failure


Secondary Outcome Measures :
  1. Difference in the complete response rates between the two treatment arms [ Time Frame: 12 weeks after the completion of therapy ]

Other Outcome Measures:
  1. Rates of toxicity [ Time Frame: 3-years ]
    Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy.


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 World Health Organization (WHO 2005) histologically type).
  • A Karnofsky performance status of at least 80;
  • Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.
  • Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.
  • 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: a creatinine clearance rate of at least 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.
  • Age >65 years or <18 years.
  • Distant metastasis,
  • Treatment with palliative intent.
  • Pregnancy or lactation.
  • a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
  • history of renal disease, unstable cardiac disease requiring treatment.
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): NCT01854203


Contacts
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Contact: Janjun Li, M.D. +86+13829745245 lijj@sysucc.org.cn
Contact: Lizhi Liu, M.D. +86+13660528375 liulizh@sysucc.org.cn

Locations
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China, Guangdong
Cancer Center,Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jian-jun Li, MD    +862087343381    lijj@sysucc.org.cn   
China
State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University Not yet recruiting
Guangzhou, China, 510060
Principal Investigator: Jian-jun Li, M.D.         
Sub-Investigator: Li-zhi Liu, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: yong Su, M.D. Sun Yat-sen University
Principal Investigator: Janjun Li, M.D. Sun Yat-sen University
Principal Investigator: Lizhi Liu, M.D. Sun Yat-sen University
More Information
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Responsible Party: Jian-jun Li, Dr, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01854203    
Other Study ID Numbers: ChiECRCT-2013003
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013
Keywords provided by Jian-jun Li, Sun Yat-sen University:
Cisplatin
neoadjuvant chemotherapy
intensity-modulated radiation therapy
concurrent chemoradiotherapy
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
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs