Oesophageal Trial

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000700639

Enrollment

250

Registered

2005-11-01

Start date

1994-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

6 months of preoperative chemotherapy and radiotherapy followed by surgery vs surgery alone

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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

Outcome results