A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx
- Determine the organ preservation rate in patients with stage III or IV squamous cell
carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed
by paclitaxel with concurrent radiotherapy.
- Determine the feasibility and toxicity of this regimen in these patients.
- Determine the utility of pre- and post-treatment organ function instruments on
swallowing ability and voice quality in patients treated with this regimen.
- Determine the disease-free survival and patterns of failure of patients treated with
- Determine the objective tumor response rate (complete and partial response) in these
patients following treatment with 2 courses of induction therapy with paclitaxel and
- Determine changes in quality of life of patients treated with this regimen.
- Determine whether the presence of human papilloma virus infection and p-glycoprotein
correlates with outcome in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease site
(larynx vs oropharynx).
Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by
carboplatin IV over 30-60 minutes on days 1 and 22. Within 28 days after completion of
induction therapy, patients with responding or stable disease receive paclitaxel IV over 60
minutes on days 1, 8, 15, 22, 29, 36, and 43 and radiotherapy once daily, 5 times weekly,
for 7 weeks beginning on day 1.
Within 6-8 weeks after completion of therapy, patients who initially had bulky neck disease
(N3) or who have residual palpable lymphadenopathy undergo surgical neck dissection.
Patients with N1-N2 disease with complete response may also undergo neck dissection.
Patients with initial complete response who recur at the primary site undergo surgical
Quality of life is assessed at baseline, after induction therapy, and at 3, 12, and 24
months after completion of all therapy.
Patients are followed at 6 weeks, 3 months, every 6-8 weeks for 1 year, every 3 months for 1
year, every 4 months for 1 year, and then every 6 months for 5 years thereafter.
PROJECTED ACCRUAL: A total of 110 patients (55 per stratum) will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Organ preservation rate
Anthony J. Cmelak, MD
Vanderbilt-Ingram Cancer Center
United States: Federal Government
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|Mercy Medical Center - Sioux City||Sioux City, Iowa 51104|
|Siouxland Hematology-Oncology Associates, LLP||Sioux City, Iowa 51101|
|St. Luke's Regional Medical Center||Sioux City, Iowa 51104|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|Aultman Cancer Center at Aultman Hospital||Canton, Ohio 44710-1799|
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44109|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Marshfield Clinic - Marshfield Center||Marshfield, Wisconsin 54449|
|Marshfield Clinic - Indianhead Center||Rice Lake, Wisconsin 54868|
|Wesley Medical Center||Wichita, Kansas 67214|
|Via Christi Cancer Center at Via Christi Regional Medical Center||Wichita, Kansas 67214|
|Mary Babb Randolph Cancer Center at West Virginia University Hospitals||Morgantown, West Virginia 26506|
|St. Vincent Hospital Regional Cancer Center||Green Bay, Wisconsin 54307-3508|
|St. Mary's Hospital Medical Center - Green Bay||Green Bay, Wisconsin 54303|
|Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center||Green Bay, Wisconsin 54301-3526|
|Green Bay Oncology, Limited at St. Mary's Hospital||Green Bay, Wisconsin 54303|
|Bay Area Cancer Care Center at Bay Area Medical Center||Marinette, Wisconsin 54143|
|Baptist Cancer Institute - Jacksonville||Jacksonville, Florida 32207|
|Southwest Medical Center||Liberal, Kansas 67901|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Hematology Oncology Associates - Skokie||Skokie, Illinois 60076|
|Mercy Hospital and Medical Center||Chicago, Illinois 60616|
|Hematology and Oncology Associates||Chicago, Illinois 60611|
|Ingalls Cancer Care Center at Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Midwest Center for Hematology/Oncology||Joliet, Illinois 60432|
|Hematology/Oncology of the North Shore at Gross Point Medical Center||Skokie, Illinois 60076|
|Cancer Center of Kansas, PA - Dodge City||Dodge City, Kansas 67801|
|Cancer Care and Hematology Specialists of Chicagoland - Niles||Niles, Illinois 60714|
|Cancer Center of Kansas, PA - Chanute||Chanute, Kansas 66720|
|Cancer Center of Kansas, PA - El Dorado||El Dorado, Kansas 67042|
|Cancer Center of Kansas, PA - Kingman||Kingman, Kansas 67068|
|Cancer Center of Kansas, PA - Newton||Newton, Kansas 67114|
|Cancer Center of Kansas, PA - Parsons||Parsons, Kansas 67357|
|Cancer Center of Kansas, PA - Pratt||Pratt, Kansas 67124|
|Cancer Center of Kansas, PA - Salina||Salina, Kansas 67401|
|Cancer Center of Kansas, PA - Wellington||Wellington, Kansas 67152|
|Cancer Center of Kansas, PA - Wichita||Wichita, Kansas 67214|
|Associates in Womens Health, PA - North Review||Wichita, Kansas 67208|
|Cancer Center of Kansas, PA - Medical Arts Tower||Wichita, Kansas 67208|
|Cancer Center of Kansas, PA - Winfield||Winfield, Kansas 67156|
|Guthrie Cancer Center at Guthrie Clinic Sayre||Sayre, Pennsylvania 18840|
|Watson Clinic, LLC||Lakeland, Florida 33804-5000|