SWOG clinical trial number
S0356
Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Abbreviated Title
ESOPHAGEAL
Participants
NCORP,
Members, Medical Oncologists, Radiation Oncologists, Surgeons
Treatment
5-Fluorouracil
Oxaliplatin
Biopsy-proven, non-recurrent, primary adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or GE junction. If primary cancer is < 26 cm from incisors, must have bronchoscopy and negative cytology. Dz must be confined to esophagus and peri-esophageal soft tissue. Tumor at GE junction must be confined to no greater than 2 cm into the gastric cardia. Must have clinical Stage II or III disease, determined by CT or MRI. If no mass detected by CT or MRI, EUS is required. Must have PET scan. Must not have celiac axis nodes greater than or equal to 1.5 cm. Any palpable supraclavicular lymph node must be biopsied and found to have no evidence of metastatic esophageal cancer. Must submit specimens for path review and correlative studies. No prior chemo or radiation for this tumor. No previous resection or attempted resection of an esophageal cancer. Zubrod Performance Status 0-2. ANC greater than or equal to 1,500/mcl. WBC greater than or equal to 3,000/mcl. Hemoglobin greater than or equal to 10.0 g/dl. Serum albumin greater than or equal to 3 g/dl. Direct serum bilirubin less than or equal to IULN. Serum creatinine less than or equal to 1.5 x IULN. Must not have peripheral neuropathy greater than or equal to Grade 2. Must be 6 months beyond any documented myocardial infarction and/or cerebrovascular event. Must not have active pneumonia or inflammatory lung infiltrate. Must not be pregnant or nursing. No prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or any other cancer for which the patient has been disease-free for five years.
2011
Excision repair cross-complementation group 1 (ERCC1) gene expression (GE) is associated with outcome in stage II-III esophageal adenocarcinoma (EA) patients treated with preoperative platinum-based chemoradiation (CRT) in a phase II cooperative study (SWOG 0356)
P Bohanes;B Goldman;J Benedetti;C Blanke;L Leichman;S Iqbal;C Thomas;C Corless;P Gold;H Lenz Journal of Clinical Oncology 29:(suppl 4: abstr 2); ASCO GI Cancers Symposium 2011, oral presentation
S0356: A phase II clinical and prospective molecular trial with oxaliplatin, fluorouracil, and external-beam radiation therapy before surgery for patients with esophageal adenocarcinoma [PMID22025151;PMC3236655]
LP Leichman;B Goldman;C Thomas;K Billingsley;C Corless;J Benedetti;HJ Lenz;S Iqbal;P Gold;CD Blanke Journal of Clinical Oncology, 29(34):4555-4560; 2011 Oct 24 [Epub ahead of print];
Association of excision repair cross- comple-mentation Group 1 (ERCC1) gene expression
(GE) with outcome in stage II-III esophageal
adenocarcinoma (EA) patients treated with
preoperative platinum-based chemoradiation
(CRT) in a phase II cooperative group study
(SWOG S0356)
PO Bohanes;B Goldman;L Leichman;CD Blanke;S Iqbal;CR Thomas;C Corless;KG Billingsley;KD Danenberg;W Zhang;J Benedetti;PJ Gold;HJ Lenz Journal of Clinical Oncology 29: 2011 (suppl; abstr 4023); American Society of Clinical Oncology 2011 meeting, poster discussion;
2010
An updated report on the pathologic complete response and survival outcome of Southwest Oncology Group (SWOG S0356): A phase II trial of oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA) with molecular correlates
L Leichman;B Goldman;C Thomas;K Billingsley;C Corless;H Lenz;S Iqbal;J Benedetti;P Gold;C Blanke American Society of Therapeutic Radiation Oncologists (ASTRO) Annual Meeting; oral
2009
Oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA): a Southwest Oncology Group (SWOG) phase II trial with molecular correlates (S0356)
L Leichman;B Goldman;C Thomas;K Billingsley;C Corless;HJ Lenz;S Iqbal;J Benedetti;P Gold;CD Blanke Journal of Clinical Oncology 27:15s, abst.#4513
