None listed
Conditions
Interventions
Oxaliplatin is designated chemically as [SP-4-2]-(1R,2R)-(cyclohexane-1,2-diamine-k2N,Nÿ¿ÿ´ (oxalato(2-)-k2O1,O2]platinum (II) given by intravenous infusion. This is a single arm open label Phase II study of chemo-radiation of localised oesophageal cancer with Oxaliplatin, continuous infusion fluorouracil and radiation. The duration of the study participation will include for each patient a 1 week inclusion and treatment planning period, followed by a 6 week treatment period, followed by a minimum of 1 week follow-up for chemotherapy related toxicities after the completion of the study treatment. In addition all patients will be followed for radiation toxicity and disease status for 2 years after the completion of the study treatment. Treatment Regimen: *5-fluorouracil via continuous intravenous infusion at the dose of 225mg/m2/day commencing on first day of radiation and continuing until delivery of last radiation fraction. *Oxaliplatin given by 2-hour intravenous infusion at a dose of 60mg/m2 weekly commencing immediately prior to the commencement of 5-fluorouracil Radiation-Standard total 54 to 60 Gy, given daily apart from weekends and public holidays
Sponsors
Study design
Eligibility
Inclusion criteria
1.Histologically confirmed localised squamous cell carcinoma of the oesophagus or adenocarcinoma of the oesophagus. 2. Performance status 0 or 1. 3. No prior chemotherapy or radiotherapy. 4. Disease evaluated by either CT or endoscopy. 5. Geographically accessible. 6. No other severe medical illness which would contra-indicate the therapy. 7. Life expectancy of greater than 3 months. 8. Bone marrow function showing white cells greater than 3.0x109/L, neutrophils greater than 2.0x109/L, platelets greater than 100x109/L. 9. Creatinine less than 2x upper limit of normal. 10.Adequate methods of contraception.
Exclusion criteria
1. Serious uncontrolled infection 2. Uncontrolled other malignancy 3. Concurrent treatment with other anti-cancer drugs 4. Respiratory function with FEV1 less than 1L 5. Oesophageal-bronchial fistula 6. Pregnancy or Lactation