A Randomised Phase II Trial of Pre-operative cisplatin, 5 fluorouracil and docetaxel ± Radiotherapy based on poor early response to standard chemotherapy for resectable adenocarcinoma of the oesophagus and/or OG Junction.

Phase 2

Completed

• Conditions: Adenocarcinoma of the Oesophagus and/or OG Junction; Cancer - Oesophageal (gullet)

• Registration Number: ACTRN12609000665235
• Lead Sponsor: AGITG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Histologically proven invasive adenocarcinoma of the oesophagus or gastroesophageal junction.

2.Tumour thought to be T2 or greater or T1 tumours that are poorly differentiated or thought to be node-positive.

3.Technically resectable disease, as assessed in consultation with the intended surgeon.

4.Tumour is sufficiently F-18 fluorodeoxyglucose (FGD) avid on the initial staging PET scan to provide sufficient contrast between tumour and the surrounding normal tissues so that a response to the neoadjuvant therapy may be assessed.

5.Written informed consent of the patient according to local ethics committee guidelines.

6.Medically fit for surgical resection, defined as having adequate cardiopulmonary function and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

1. Evidence of extrathoracic or extragastric spread apart from perigastric or mediastinal nodes, which are resectable. (Supraclavicular nodes renders the patient ineligible) 2. Tumour is located in the cervical oesophagus requiring pharyngolaryngectomy. 3. Tumour is predominantly within the stomach ie. most of the tumour is not involving the oesophagus or gastroesophageal junction. 4. Evidence of tracheo- or broncho oesophageal fistula. 5. Adequate haematological function. 6. Adequate renal function 7. Adequate liver function 8. Previous radiation therapy to the chest, previous chemotherapy within the last 5 years. 9. Previous malignancy for the previous 5 years apart from non metastatic Squamous Cell Carcinoma of the skin, Basal Cell Carcinoma or carcinoma in situ of the cervix. 10. Pregnant, lactating or inadequate contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the histological response to the neoadjuvant therapy regime[Tumour samples will be taken at baseline and at surgery (after neoadjuvant therapy). After 23 patients have completed neoadujvant treatment and no histological responses have been observed then consideration will be given to stopping that particular arm.]