Status:
COMPLETED
S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-...
Detailed Description
OBJECTIVES: Primary * Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant ox...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction
- No recurrent disease
- Primary esophageal tumor at least 20 cm below the incisors (if \< 26 cm below the incisors, a bronchoscopy must be performed and cytology must be negative)
- Esophageal disease confined to esophagus and peri-esophageal soft tissue
- Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia
- Clinical stage II or III disease by CT scan or MRI
- If no esophageal mass is detected by these methods, esophageal endoscopic ultrasound is required to determine stage
- Positron-emission tomography scan is required to confirm stage
- Measurable or non-measurable disease by x-ray, scanning, or physical examination
- No celiac axis nodes ≥ 1.5 cm
- Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed
- Palpable supraclavicular lymph nodes must be free of metastatic esophageal cancer by biopsy
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- White blood cell (WBC) count ≥ 3,000/mm\^3
- Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
- Hepatic
- Albumin ≥ 3 g/dL
- Bilirubin normal
- Renal
- Creatinine ≤ 1.5 times upper limit of normal
- Cardiovascular
- No myocardial infarction or cerebrovascular event within the past 6 months
- Pulmonary
- No active pneumonia or inflammatory lung infiltrate
- Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No peripheral neuropathy ≥ grade 2
- Not pregnant or nursing
- 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 for esophageal cancer
- No concurrent intensity-modulated radiotherapy
- Surgery
- No prior surgical resection or attempted surgical resection of esophageal cancer
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00086996
Start Date
September 1 2004
End Date
August 1 2011
Last Update
October 11 2013
Active Locations (143)
Enter a location and click search to find clinical trials sorted by distance.
1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
2
Providence Cancer Center
Anchorage, Alaska, United States, 99508
3
Highlands Oncology Group - Springdale
Bentonville, Arkansas, United States, 72712
4
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546