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Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT01417390
Recruitment Status : Unknown
Verified March 2014 by Tao Xu, First People's Hospital of Foshan.
Recruitment status was:  Recruiting
First Posted : August 16, 2011
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Tao Xu, First People's Hospital of Foshan

Brief Summary:
The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy using gemcitabine and cisplatin in NPC patients.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Drug: Gemcitabine and cisplatin Drug: Cisplatin Phase 2

Detailed Description:
Patients presented with non-keratinizing NPC and stage Ⅲ-Ⅳb T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical Intensity modulated radiation therapy (Trilogy, Varian), and cisplatin (40mg/m2) every weeks for six cycles during radiotherapy. Radiation is delivered to GTV at 70 Gy in 30 fractions, CTV1 at at 60 Gy in 30 fractions and CTV2 at 54 Gy in 30 fractions. Patients in the investigational arm receive gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy. The primary end point is response rates after radiotherapy, failure-free survival (FFS) and toxic effects and treatment compliance. Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS). All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
Study Start Date : November 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Concurrent chemoradiotherapy
Patients receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy
Drug: Cisplatin
Patients receive radical radiotherapy and cisplatin (40mg/m2) every week for six cycles during radiotherapy
Experimental: Inductive and concurrent
Patients receive Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy.
Drug: Drug: Gemcitabine and cisplatin
Patients receive Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy.
Other Name: Gemcitabine and cisplatin



Primary Outcome Measures :
  1. 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.


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 ]
    the latency to the first local failure

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

  4. The initial response rates after treatments [ Time Frame: 16 weeks after completion of radiotherapy ]


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Ages Eligible for Study:   18 Years to 60 Years   (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).
  • Karnofsky scale (KPS) > 70.
  • 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: 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.
  • Age >60 years or <18 years.
  • Treatment with palliative intent.
  • Pregnancy or lactation.
  • Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • Any severe intercurrent disease including unstable cardiac disease, chronic hepatitis, renal disease, diabetes with poor control, and emotional disturbance.

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): NCT01417390


Contacts
Contact: Wei wei Hong, M.D. +86-757-83162835 wwhong@fsyyy.com

Locations
China, Guangdong
Wei-wei Hong Recruiting
Foshan, Guangdong, China, 528000
Contact: Wei wei Hong, M.D.         
Sub-Investigator: Tao Xu, M.D.         
Sponsors and Collaborators
First People's Hospital of Foshan

Publications:

Responsible Party: Tao Xu, Foshan head and neck group, First People's Hospital of Foshan
ClinicalTrials.gov Identifier: NCT01417390     History of Changes
Other Study ID Numbers: FSHNG-1108
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

Keywords provided by Tao Xu, First People's Hospital of Foshan:
Nasopharyngeal Carcinoma

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
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