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DOCTOR: A randomized phase II trial of preoperative cisplatin, 5-fluorouracil, and docetaxel with or without radiotherapy based on poor early response to standard chemotherapy for resectable adenocarcinoma of the esophagus and/or OG junction
- Source :
- Journal of Clinical Oncology. 30:TPS4145-TPS4145
- Publication Year :
- 2012
- Publisher :
- American Society of Clinical Oncology (ASCO), 2012.
-
Abstract
- TPS4145 Background: Surgery forms the mainstay of curative treatment for oesophageal and gastro-oesophageal junction adenocarcinoma (OAC). Preoperative chemotherapy (CTX) with or without concurrent radiotherapy (CRT) have resulted in modest improvements in outcome. Patients who demonstrate a histological response in the resected specimen following pre-operative therapy (CTX or CRT) have consistently better survival than non-responders. Recent data suggests that early metabolic response, assessed by FDG-PET scan performed 14+/-1 days after the start of CTX compared with a baseline PET scan, is predictive of a histological response and improved survival. Increasing the proportion of responders to pre-operative therapy remains one of the major challenges facing patients with localised OAC. Methods: 150 patients with resectable adenocarcinona of the oesophagus or GOJ will be registered and given 1 cycle of cisplatin and 5FU (CF). Patients will undergo a series of baseline tests including endoscopy, endoscopic ultrasound and 18FDG-PET. At Day 15 of the initial CF cycle the PET will be repeated. Patients with a PET response (≥ 35% reduction in SUVmax) to initial treatment will continue with CF as standard treatment prior to surgery. PET non-responders (< 35% reduction in SUVmax) will be randomized equally to receive either docetaxel, cisplatin and 5FU (DCF) or DCF plus radiatiotherapy. Following completion of the preoperative chemotherapy /chemoradiotherapy patients will have their cancer surgically removed. The primary end point is major histological response (
- Subjects :
- Cisplatin
Cancer Research
medicine.medical_specialty
Chemotherapy
business.industry
medicine.medical_treatment
medicine.disease
Gastroenterology
Surgery
Radiation therapy
medicine.anatomical_structure
Oncology
Docetaxel
Fluorouracil
Internal medicine
Medicine
Adenocarcinoma
Preoperative chemotherapy
Esophagus
business
medicine.drug
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 30
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi...........8624a1d0d2d11d73ad78cde3dbaddd70