Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
- Compare the 1-year rate of local and regional disease control in patients with newly
diagnosed stage II, III, or IV squamous cell carcinoma of the head and neck treated
with concurrent radiotherapy and chemotherapy comprising carboplatin and paclitaxel
with vs without amifostine.
- Compare the 3- and 6-month incidence of grade 2 or 3 chronic xerostomia in patients
treated with these regimens.
- Compare the incidence of grade 3 and 4 mucositis after radiotherapy in patients treated
with these regimens.
- Compare the median duration of dependence on percutaneous endoscopic gastrectomy (PEG)
for adequate nutrition in patients treated with these regimens.
- Compare the duration of grade 3 and 4 mucositis in patients treated with these
- Compare the 3-, 6-, and 12-month dependence on PEG in patients treated with these
- Compare time to disease progression in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Compare 2-year local and regional disease control in patients treated with these
- Compare 2-year survival of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin and paclitaxel once weekly for 6 weeks. Patients
also undergo radiotherapy, concurrently with chemotherapy, once daily for 4 weeks and
then twice daily for 2 weeks.
- Arm II: Patients receive chemoradiotherapy as in arm I. Patients also receive
amifostine subcutaneously once daily.
Quality of life is assessed at baseline and then at 8, 12, 24, and 52 weeks after completion
of study therapy.
Patients are followed at 8, 12, 24, and 52 weeks.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Rate of local/regional control (LRC) 1 year after beginning treatment
Robert I. Haddad, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Bethke Cancer Center at Emerson Hospital||Concord, Massachusetts 01742|
|Lowell General Hospital||Lowell, Massachusetts 01854|
|Hudner Oncology Center at Saint Anne's Hospital - Fall River||Fall River, Massachusetts 02721|
|NSMC Cancer Center - Peabody||Peabody, Massachusetts 01960|