Clinical Trial: Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Rando
Brief Summary: The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III & IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.
Detailed Summary:
Sponsor: Samsung Medical Center
Current Primary Outcome: To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only [ Time Frame: 18 months after the enrollment of the last patients ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only [ Time Frame: 18 months after enrollemnt of last patients ]
- To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only [ Time Frame: 18 months after the enrollment of the last patient ]
- To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only [ Time Frame: 18 months after the enrollment of the last patient ]
Original Secondary Outcome: Same as current
Information By: Samsung Medical Center
Dates:
Date Received: February 21, 2011
Date Started: November 2010
Date Completion: December 2016
Last Updated: April 19, 2016
Last Verified: April 2016
