A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer
- Determine the pathologic complete response rate in patients with locally advanced
cancer of the esophagus or gastroesophageal junction treated with radiotherapy
administered concurrently with paclitaxel, carboplatin, and fluorouracil before
- Determine the tolerability of this regimen in these patients.
- Determine the tumor response rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Assess the relationship between the presence of genetic polymorphisms in these patients
and the toxicity of this regimen.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and
fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients
undergo radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the
absence of disease progression or unacceptable toxicity. Patients with stable or responding
disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete
dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery,
patients who underwent curative resection may receive a maximum of 2 additional courses of
paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2
weeks before surgery.
Patients are followed every 3 months for 4 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Proportion of successes
Aminah Jatoi, MD
United States: Federal Government
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|Fairview Ridges Hospital||Burnsville, Minnesota 55337|
|Mercy and Unity Cancer Center at Mercy Hospital||Coon Rapids, Minnesota 55433|
|Duluth Clinic Cancer Center - Duluth||Duluth, Minnesota 55805-1983|
|CCOP - Duluth||Duluth, Minnesota 55805|
|Miller - Dwan Medical Center||Duluth, Minnesota 55805|
|Fairview Southdale Hospital||Edina, Minnesota 55435|
|Mercy and Unity Cancer Center at Unity Hospital||Fridley, Minnesota 55432|
|Minnesota Oncology Hematology, PA - Maplewood||Maplewood, Minnesota 55109|
|Virginia Piper Cancer Institute at Abbott - Northwestern Hospital||Minneapolis, Minnesota 55407|
|Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center||Robbinsdale, Minnesota 55422-2900|
|Park Nicollet Cancer Center||St. Louis Park, Minnesota 55416|
|United Hospital||St. Paul, Minnesota 55102|
|Ridgeview Medical Center||Waconia, Minnesota 55387|
|Minnesota Oncology Hematology, PA - Woodbury||Woodbury, Minnesota 55125|
|Sanford Cancer Center at Sanford USD Medical Center||Sioux Falls, South Dakota 57117-5039|
|Medical X-Ray Center, PC||Sioux Falls, South Dakota 57105|
|Avera Cancer Institute||Sioux Falls, South Dakota 57105|
|Wesley Medical Center||Wichita, Kansas 67214|
|Via Christi Cancer Center at Via Christi Regional Medical Center||Wichita, Kansas 67214|
|Southwest Medical Center||Liberal, Kansas 67901|
|Cancer Center of Kansas, PA - Dodge City||Dodge City, Kansas 67801|
|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|