A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer
OBJECTIVES:
- 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
esophagectomy.
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Proportion of successes
No
Aminah Jatoi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068789
NCT00022139
January 2002
Name | Location |
---|---|
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 |