Clinical Trial: Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer

Brief Summary: The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

Detailed Summary:

TRIAL DESIGN:

Phase III trial of induction therapy with docetaxel followed by chemoradiotherapy versus chemoradiotherapy alone in patients with nodal stage N2 or N3 head and neck cancer

OBJECTIVES:

Primary

  • To determine the effect on overall survival when induction chemotherapy is administered prior to chemoradiotherapy in patients with N2 or N3 disease.

Secondary

  • To determine the effect of induction chemotherapy when administered prior to chemoradiotherapy on distant failure-free survival, failure pattern, progression free survival and quality of life.

TREATMENT PLAN:

  • After eligibility is confirmed, patients will be randomized to one of two treatment arms:

Arm A - Induction + chemoradiotherapy

Arm B - Chemoradiotherapy alone

  • Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (day 1), cisplatin (day 1), and 5-fluorouracil (days 1-5). Total duration of 6 weeks.
  • Chemoradiotherapy: Five 14-day cycles of docetaxel (day 1), 5-fluorouracil (day 0-4), and hydroxyurea (days 0-4) with twice daily radiation (days 1-5). Total duration of 10 weeks.
  • All patients will undergo surgical evaluation after chemoradiation for possible neck dissection.
  • Sponsor: University of Chicago

    Current Primary Outcome: Overall survival [ Time Frame: Indefinitely ]

    Original Primary Outcome: Overall survival

    Current Secondary Outcome:

    • Distant failure-free survival (DFFS) [ Time Frame: Indefinitely ]
    • failure pattern [ Time Frame: Indefinitely ]
    • progression free survival [ Time Frame: Indefinitely ]
    • quality of life (QOL) [ Time Frame: 5 years ]


    Original Secondary Outcome:

    • Distant failure-free survival (DFFS)
    • failure pattern
    • progression free survival
    • quality of life (QOL)


    Information By: University of Chicago

    Dates:
    Date Received: June 30, 2005
    Date Started: November 2004
    Date Completion: August 2013
    Last Updated: October 9, 2012
    Last Verified: October 2012