A Phase 2 Study of Palliative Chemo-Radiotherapy With Carbo-Taxol in Non-Curative Cancer of the Esophagus
This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a palliative course of external beam radiation treatment improves both dysphagia relief and patient quality of life in patients with unresectable esophageal cancer.
• Biopsy proven carcinoma of the esophagus.
• Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness.
• Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids.
• ECOG Performance status ≤ 2.
• Patients able to begin treatment within 14 days of signing the informed consent form.
• Patient is at least 18 years old.
• Hematological function as defined by the following laboratory parameters:
‣ Hemoglobin \> 100g/L
⁃ Platelet count \> 100x10E9/L
⁃ Absolute neutrophil count \> 1.5x10E9/L
• Renal function to undergo chemotherapy as defined by the following laboratory parameters:
‣ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x the upper limit of institutional normal (≤ 5 if liver metastases)
⁃ Total bilirubin ≤ 1.5x the upper limit of institutional normal
⁃ Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
• Patients capable of childbearing are using adequate contraception.
⁃ Written and informed consent of patient.