Phase 2
N=98
S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00086996 ↗Enrolled (actual)
98
Serious AEs
7.5%
Results posted
Apr 2012
Primary outcome: Primary: Pathological Complete Response — 26 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fluorouracil (Drug); oxaliplatin (Drug); conventional surgery (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathological Complete Response |
26 | — |
| SECONDARY Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
4; 15; 1; 2; 1; 1 | — |
| SECONDARY Overall Survival |
28.3 | — |
| SECONDARY Progression-free Survival |
19.7 | — |
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-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00086996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.