Oesophageal Trial

Phase 3

Active, not recruiting

• Conditions: Oesophageal carcinoma; Cancer - Oesophageal (gullet)

• Registration Number: ACTRN12605000700639
• Lead Sponsor: AGITG/NHMRC Clinical Trials Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Histologically proven invasive squamous cell carcinoma or adenocarcinoma of the oesophagus.Technically resectable disease, as assessed in consultation with intended surgeon, with no planned post-operative anti-tumour treatment.No evidence of extrathoracic spread. (Tumour in supraclavicular and/or coeliac nodes renders patient ineligible.)Tumour is NOT located in cervical oesophagus requiring pharyngo-oesophagectomy.Tumour is NOT predominantly below the oesophagogastric junction and involving the stomach. (i.e. Most of the macroscopically visible tumour must be above the O-G junction and technically within the oesophagus.)Medically fit for surgical resection, defined as having adequate cardiopulmonary function and ECOG performance status of 0 or 1.Adequate haematological function, defined as having WBC > 4 x 109/litre and platelets > 100 x 109/litre.Adequate renal function, defined as creatinine clearance > 60 ml/min calculated (using Cockcroft & Gault formula - see Appendix 6). If calculated creatinine clearance is < 60ml/min, glomerular filtration rate can be measured by an alternative method. If results from this are creatinine clearance > 60mls/min the patient is eligible.No previous radiotherapy to the chest, no previous chemotherapy.No previous malignancy, with the exception of non-metastatic SCC of skin, other non-melanoma skin cancer, carcinoma in situ of the cervix. Cases for Special Eligibility with regard to this criteria may be presented to the study chair for discussion.No evidence of tracheo- or broncho-oesophageal fistula.Not pregnant or lactating.Written informed consent of the patient according to local ethics committee guidelines.

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified