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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Jian-jun Li, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01854203
First received: May 10, 2013
Last updated: July 28, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Nasopharyngeal Carcinoma
Drug: Inductive chemotherapy + concurrent cisplatin and IMRT
Drug: Inductive chemotherapy + IMRT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    Overall survival is calculated from randomization to death from any cause.

  • Failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

  • Locoregional failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    the latency to the first local failure

  • Distant failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    The latency to the first remote failure


Secondary Outcome Measures:
  • Difference in the complete response rates between the two treatment arms [ Time Frame: 12 weeks after the completion of therapy ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Rates of toxicity [ Time Frame: 3-years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: July 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854203

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

Locations
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
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

No publications provided

Responsible Party: Jian-jun Li, Dr, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01854203     History of Changes
Other Study ID Numbers: ChiECRCT-2013003
Study First Received: May 10, 2013
Last Updated: July 28, 2013
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Cisplatin
neoadjuvant chemotherapy
intensity-modulated radiation therapy
concurrent chemoradiotherapy

Additional relevant MeSH terms:
Pharyngeal Neoplasms
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014