Clinical Trial: S0427, Combination Chemotherapy & RT in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, With and Without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients With Advanced

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known whether giving combination chemotherapy together with radiation therapy is more effective than giving cisplatin together with radiation therapy in treating cancer of the oropharynx.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and radiation therapy to see how well they work compared to cisplatin and radiation therapy in treating patients with stage III or stage IV cancer of the oropharynx.


Detailed Summary:

OBJECTIVES:

Primary

  • Compare the overall survival of patients with previously untreated stage III or IV squamous cell carcinoma of the oropharynx treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by radiotherapy and cisplatin versus radiotherapy and cisplatin only.
  • Compare the progression-free survival in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life and functional status of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary cancer site (base of tongue vs other), nodal extent (N0-1 vs N2-3), radiotherapy plan (conventional [2-D or 3-D conformal radiotherapy] vs intensity modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (induction chemotherapy with or without salvage surgery followed by chemoradiotherapy)

    • Induction chemotherapy with or without early salvage surgery: Patients receive docetaxel IV over 1 hour and cisplatin over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 1-3 courses. Patients achieving complete or partial response at the primary site after course 1 receive 2 additional courses of therapy and then proceed to chemoradiotherapy within 3-4 weeks after completion of fluorouracil administration. Patients with stable disease or
      Sponsor: Southwest Oncology Group

      Current Primary Outcome: Survival at 2 years [ Time Frame: 2 years ]

      Original Primary Outcome:

      Current Secondary Outcome:

      • Progression-free survival by FACT-HN CTCAE v 3.0 at 2 years [ Time Frame: 2 years ]
      • Toxicity by CTCAE v 3.0 after induction chemotherapy or after chemotherapy and radiotherapy [ Time Frame: after chemotherapy ]
      • Incidence of surgical resection [ Time Frame: after treatment ]
      • Site of relapse [ Time Frame: at relapse ]
      • Quality of life by FACT-HN week 19 after first and second registration date (arm 1) [ Time Frame: after first and second registrations ]


      Original Secondary Outcome:

      Information By: Southwest Oncology Group

      Dates:
      Date Received: December 21, 2005
      Date Started: December 2005
      Date Completion:
      Last Updated: October 3, 2012
      Last Verified: October 2012