A randomised Phase II study of two pre-operative chemoradiotherapy regimes (oxaliplatin and capecitabine followed by radiotherapy with either oxaliplatin and capecitabine or paclitaxel and carboplatin) for resectable oesophageal cancer.

• Conditions: Histologically confirmed operable oesophageal cancer; MedDRA version: 14.1Level: LLTClassification code 10056104Term: Squamous cell carcinoma of oesophagusSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10056092Term: Adenocarcinoma of oesophagusSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000640-10-GB
• Lead Sponsor: Velindre NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-04
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically confirmed operable oesophageal cancer (adenocarcinoma) Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N1-3 using TNM7 staging) Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET WHO performance status 0-1 Adequate haematological, renal, respiratory, cardiac and hepatic function The patient has provided written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Histologically confirmed operable oesophageal cancer (squamous cell carcinoma) Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG. Patients with any previous treatment for oesophageal carcinoma. Siewert type 3 oesophago-gastric tumours. T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura. Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation: Evidence of other distant metastases. Para-aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on EUS. Invasion of tracheo-bronchial tree, aorta, pericardium or lung. Lymphadenopathy encasing the coeliac axis (as described above, patients with single nodes lying anterior to the origin of the splenic artery and anterior to the origin of the coeliac axis are not excluded). Any patient with a single significant medical condition which is thought likely to compromise his or her ability to tolerate any of the above therapies. Specific contra-indications to surgery, chemotherapeutic agents (including known allergies to chemotherapy) or radiotherapy. Pregnant or lactating women and fertile women who will not be using adequate contraception during the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified