Esophageal Cancer Clinical Trial
Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Summary
RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.
Full Description
OBJECTIVES:
Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction.
Determine the overall and disease-free survival of patients treated with this regimen.
Determine the treatment-related toxicity of this regimen in these patients.
Determine the tolerance to surgical salvage in patients treated with this regimen.
Determine the morbidity and mortality of surgical salvage in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and 34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence of unacceptable toxicity.
Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96.
Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.
Patients are followed periodically.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
Primary (non-recurrent) disease
Amenable to resection
Stage greater than T1, N0 by endoscopic ultrasound
Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue
Tumor may not extend more than 2 cm into the stomach
No multiple primary carcinomas of the esophagus
No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus
No evidence of disseminated cancer
Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies
Palpable supraclavicular nodes must be negative for cancer by biopsy
Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion
No celiac adenopathy greater than 2 cm
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Zubrod 0-1
Life expectancy
Not specified
Hematopoietic
Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 150,000/mm^3
Hemoglobin at least 10 g/dL
Hepatic
Not specified
Renal
Creatinine no greater than 1.5 mg/dL AND/OR
Creatinine clearance at least 65 mL/min
Calcium no greater than 11 mg/dL
Cardiovascular
No uncontrolled heart disease
No uncontrolled hypertension
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to comprehend study requirements and considered likely to comply with study parameters
No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix
No uncontrolled diabetes
No hypersensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
More than 5 years since prior systemic chemotherapy
Endocrine therapy
Not specified
Radiotherapy
No prior chest or upper abdomen radiotherapy
Surgery
No prior esophageal or gastric surgery
Other
No concurrent photodynamic therapy
No other concurrent investigational agents for esophageal carcinoma
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There are 89 Locations for this study
Burbank California, 91505, United States
Hayward California, 94545, United States
Mission Hills California, 91346, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Pleasanton California, 94588, United States
San Pablo California, 94806, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06511, United States
Miami Florida, 33176, United States
Panama City Florida, 32405, United States
Savannah Georgia, 31403, United States
Chicago Illinois, 60608, United States
Beech Grove Indiana, 46107, United States
Dubuque Iowa, 52001, United States
Baton Rouge Louisiana, 70816, United States
New Orleans Louisiana, 70121, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Escanaba Michigan, 49431, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Iron Mountain Michigan, 49801, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48909, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, 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
Hattiesburg Mississippi, 39401, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
St Louis Missouri, 63110, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89106, United States
Long Branch New Jersey, 07740, United States
Marlton New Jersey, 08053, United States
Red Bank New Jersey, 07701, United States
Toms River New Jersey, 08755, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87131, United States
Brooklyn New York, 11203, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Rutherfordton North Carolina, 28139, United States
Wilson North Carolina, 27893, United States
Akron Ohio, 44309, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Kettering Ohio, 45429, United States
Middletown Ohio, 45044, United States
Salem Ohio, 44460, United States
Troy Ohio, 45373, United States
Wooster Ohio, 44691, United States
Xenia Ohio, 45385, United States
Bryn Mawr Pennsylvania, 19010, United States
Drexel Hill Pennsylvania, 19026, United States
Paoli Pennsylvania, 19301, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19141, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Houston Texas, 77030, United States
Murray Utah, 84107, United States
Ogden Utah, 84403, United States
Provo Utah, 84604, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84143, United States
Wheeling West Virginia, 26003, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Marinette Wisconsin, 54143, United States
Oconto Falls Wisconsin, 54154, United States
Sturgeon Bay Wisconsin, 54235, United States
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