Status:
UNKNOWN
A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer
Lead Sponsor:
Lisette Nixon
Collaborating Sponsors:
Cancer Research UK
Conditions:
Oesophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less than a quarter have resectable disease at diagnosis. There is a general lack of consistency in the standard ...
Eligibility Criteria
Inclusion
- Histologically confirmed operable oesophageal cancer (adenocarcinoma)
- Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N13 using TNM7 staging)
- Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET
- WHO performance status 01
- Adequate haematological, renal, respiratory, cardiac and hepatic function
- The patient has provided written informed consent.
Exclusion
- 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 oesophagogastric 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 metastases in liver, lung, bone or other distant metastases.
- Abdominal 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 contraindications 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2016
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01843829
Start Date
October 1 2013
End Date
May 1 2016
Last Update
March 24 2014
Active Locations (12)
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1
Bristol Oncology and Haematology Centre
Bristol, United Kingdom
2
Valindre NHS
Cardiff, United Kingdom
3
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
4
Royal Derby Hospital
Derby, United Kingdom