IG9401

Protocol Title

A Randomised Phase III Clinical Trial Comparing Surgery Alone with Concurrent Preoperative Chemotherapy and Radiation Followed by Surgery For Localised Resectable Carcinoma of the Oesophagus

Purpose of the Study

The optimal treatment of operable oesophageal cancer has been clouded by contradictory findings from several studies in recent years. This trial addressed the question of the efficacy of pre-operative therapy for oesophageal cancer in relation to progression-free survival and overall survival. In addition, there are almost no data reporting the quality of life of this patient population in the literature at the moment. This trial will describe the quality of life of patients prior to the initiation of treatment and subsequent to treatment as well as clarification of the impact of pre-operative neoadjuvant combined modality therapy compared to the standard of care, surgery alone.

KEY ELIGIBILITY CRITERIA

Inclusion Criteria

1. Histologically proven invasive squamous cell carcinoma or adenocarcinoma of the oesophagus.
2. Technically resectable disease.
3. Tumour is not located in cervical oesophagus.
4. Tumour is not predominantly below the oesophagogastric junction and involving the stomach.
5. Medically fit for surgical resection.
6. No previous radiotherapy to the chest, no previous chemotherapy.
7. Not pregnant or lactating.
8. Written informed consent of the patient according to local ethics committee guidelines.

Exclusion Criteria

No exclusion criteria

Principal Investigator

Professor Bryan Burmeister

More Information Available

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR), please click here.

Funding

Funded for first three years by National Health and Medical Research Council (Australia) via the University of Sydney and NHMRC Clinical Trials Centre (Australia)