Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by First People's Hospital of Foshan
Sponsor:
Information provided by (Responsible Party):
Tao Xu, First People's Hospital of Foshan
ClinicalTrials.gov Identifier:
NCT01417390
First received: August 15, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Nasopharyngeal Carcinoma
Drug: Drug: Gemcitabine and cisplatin
Drug: Cisplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by First People's Hospital of Foshan:

Primary Outcome Measures:
  • 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.


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

  • 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

  • The initial response rates after treatments [ Time Frame: 16 weeks after completion of radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Cisplatin
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 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).
  • 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.
  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: 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
  More Information

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
Study First Received: August 15, 2011
Last Updated: March 6, 2014
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma
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 October 19, 2014