Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, chemoradiotherapy, oxaliplatin, cetuximab, docetaxel
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed adenocarcinoma of the esophagus (> 20 cm below the incisors) or gastroesophageal (GE) junction, untreated with chemotherapy, radiation therapy, and surgery. Endoscopy with biopsy and dilation was permitted.
- Tumor stage T2N0M0, T3N0M0, T1-3N+M0, or T1-3N0-1M1A as determined by imaging studies performed no greater than 4 weeks prior to registration, and biopsy, where appropriate. Celiac nodal metastasis (M1A disease) was permitted if other eligibility criteria were met. Data from endoscopic ultrasound and endoscopy were required for staging. The following imaging was required: CT scan with IV contrast and PET or PET+CT. If the PET/CT incorporates CT with IV contrast, then a separate CT is not required. If laparoscopy or other relevant procedures were performed, the data were to be incorporated into stage assignment. Any lesion suspicious for metastasis had to have been biopsied to prove eligibility.
- Tumor extension into cardia, if present, must have been no more than 2 cm.
- Tumors must have been considered surgically resectable (T1-3, not T4).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Granulocytes > 1,000/ mm³
- Platelets > 100,000 μL
- Creatinine normal or creatinine clearance > 60 mL/min
- Total serum bilirubin < 1.5 mg/dL
- Fertile patients must use effective contraception
- History of a curatively treated malignancy from which the patient has been disease-free for ≥ 2 years and has a survival prognosis of > 5 years
Exclusion Criteria:
- Pregnant or breast-feeding.
- Prior severe infusion reaction to a monoclonal antibody
- prior therapy specifically and directly targeting the epidermal growth factor receptor (EGFR) pathway
- Hypertension
- Uncontrolled diabetes
- Intercurrent illness that would likely interfere with protocol therapy or prevent surgical resection
Any of the following within the past 6 months:
- New York Heart Association class III-IV congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Unstable angina or myocardial infarction
Sites / Locations
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Rush-Copley Cancer Care Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Decatur Memorial Hospital Cancer Care Institute
- Hinsdale Hematology Oncology Associates
- Midwest Center for Hematology/Oncology
- Joliet Oncology-Hematology Associates, Limited - West
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- La Grange Oncology Associates - Geneva
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- Swedish-American Regional Cancer Center
- Hematology Oncology Associates - Skokie
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Saint Anthony Memorial Health Centers
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas, PA - Winfield
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Union Hospital Cancer Program at Union Hospital
- Beth Israel Deaconess Medical Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Overlook Hospital
- Cancer Institute of New Jersey at Cooper - Voorhees
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Mercy Cancer Center at Mercy Medical Center
- Aultman Cancer Center at Aultman Hospital
- St. Luke's Cancer Network at St. Luke's Hospital
- Bryn Mawr Hospital
- Cancer Center of Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- UPMC Cancer Centers
- Pottstown Memorial Regional Cancer Center
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Hematology and Oncology Associates of Northeastern Pennsylvania
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Marshfield Clinic - Lakeland Center
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Saint Michael's Hospital Cancer Center
- Marshfield Clinic - Wausau Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Experimental
Neoadjuvant therapy, Surgery, adjuvant therapy
Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery. Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician. Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.