Clinical Trial: Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx

Brief Summary: The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Detailed Summary: Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.
Sponsor: The Second People's Hospital of Sichuan

Current Primary Outcome:

  • Objective response rate [ Time Frame: 3 months after all the treatment ending ]
    Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
  • The Number of Participants with Adverse Events [ Time Frame: Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks ]
    Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 as the two measure of safety.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Survival [ Time Frame: From date of randomization until the date of death from any cause,assessed up to 5 years ]
  • Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]
  • Evaluate the Local control Rate in 1 to 5 years. [ Time Frame: Participants will be followed every year for the duration of 5 years ]
    To evaluate each year until 5 years later
  • Tumor-Free Survival [ Time Frame: From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years ]
  • Non-metastatic Rate [ Time Frame: The time from randomization until distant relapse occur,assessed up to 5 years ]


Original Secondary Outcome: Same as current

Information By: The Second People's Hospital of Sichuan

Dates:
Date Received: January 11, 2012
Date Started: March 2012
Date Completion: March 2018
Last Updated: March 18, 2012
Last Verified: March 2012