This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies.
Primary Objectives • To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens. Secondary Objectives * To determine the survival outcome with this treatment strategy. * To determine time to disease progression with this treatment strategy. * To determine the agreement between tumor CHFR methylation and detection in plasma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Paclitaxel and cisplatin: * Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. * Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Cisplatin and 5-fluorouracil: * 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32. * Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin 85 mg/m2 days 1, 15, 29.
Ronan Kelly, M.D.
Baltimore, Maryland, United States
Pathological Complete Response
CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.
Time frame: 3 years
Survival
Overall survival with given treatment strategy.
Time frame: 3 years
Time to Disease Progression
To determine time to disease progression with this treatment strategy.
Time frame: 3 years
Esophageal Tumor CHFR Methylation and Detection in Plasma
To determine the agreement between tumor CHFR methylation and detection in plasma.
Time frame: 3 years
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Oxaliplatin and 5-fluorouracil: * Oxaliplatin 85 mg/m2 days 1, 15, 29. * 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days) Cisplatin and 5-fluorouracil: * 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32. * Cisplatin 75 mg/m² days 1, 29.
Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).