Clinical Trial: TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Study of TPF (Docetaxel, Cisplatin, 5-fluorouracil) Induction Chemotherapy Followed by Surgery and Radiotherapy in Patients With Locally Advanced and Resectable Oral Squamous Cel

Brief Summary: Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.

Detailed Summary: The primary endpoint of this study is the survival rate (2, 3, 5 years) after induction chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is locoregional control rates (1, 2 years), and the safety.
Sponsor: Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: Survival rate [ Time Frame: Up to 5 years ]

To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • local control [ Time Frame: Up to 5 yeas ]
    To evaluate the 1, 2, 3, 5-year local and regional control rate and distant metastasis rate after TPF indcution chemotherapy followed by surgery and radiotherapy
  • Number of participants with adverse events [ Time Frame: Up to 5 years ]
    All adverse events, including serious adverse events, exposure of all study drugs and radiation.


Original Secondary Outcome: Same as current

Information By: Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: February 26, 2012
Date Started: January 2008
Date Completion: December 2015
Last Updated: March 1, 2012
Last Verified: February 2012