Esophageal Cancer Clinical Trial
Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy and giving them before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy followed by esophagectomy works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction.
Full Description
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction
Surgically resectable disease (T1-3; NX, N0, or N1; M1a)
T4 tumors that are not unequivocally unresectable allowed
Celiac lymph node (stations 15-20) involvement allowed
Must be considered a potential surgical candidate by a thoracic or general surgeon
No supraclavicular lymph node involvement by palpation, biopsy, or radiograph (greater than 1.5 cm)
No distant metastases
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Patients with ECOG 2 must be considered good candidates for study by treating oncologists
Life expectancy
At least 12 weeks
Hematopoietic
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST no greater than 3 times ULN
Renal
Creatinine no greater than 1.5 times ULN
Cardiovascular
No New York Heart Association class III or IV heart disease
Other
No uncontrolled infection
No other severe underlying disease that would preclude study participation
No grade 2 or greater peripheral neuropathy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
No prior chemotherapy for esophageal cancer
Endocrine therapy
Not specified
Radiotherapy
No prior radiotherapy to anticipated fields of study radiotherapy
Surgery
Not specified
Other
No concurrent diuretics
No concurrent amifostine
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There are 27 Locations for this study
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
St. Louis Park Minnesota, 55416, United States
St. Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
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