NCT01843829

A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer

A Randomised Phase II Study of Two Pre-operative Chemoradiotherapy Regimens (Oxaliplatin and Capecitabine Followed by Radiotherapy With Either Oxaliplatin and Capecitabine or Paclitaxel and Carboplatin) for Resectable Oesophageal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Lisette Nixon · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of care for patients across UK hospitals. Patients are either treated with a) chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by removal of the tumour by surgery, as part of their standard of care. Recent research supports the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and preventing the disease from spreading than taking chemotherapy alone. However, there is no definitive way of identifying which treatment is best without a clinical trial. Evidence suggests that the effect of the chemoradiotherapy currently used as standard practice may be improved and the side effects reduced by using a different chemoradiotherapy combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy before being randomised to receive two different chemoradiotherapy regimens (carboplatin and paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in previous studies. Patients will then have their tumour removed. The best chemoradiotherapy regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be compared with chemotherapy alone. The efficacy of the regimens will be measured by counting the number of patients who i) remain free from cancer, ii)have local or distant spread of their cancer, iii) are successfully recruited and iv) experience toxicities. A specific set of toxicity criteria will be used to monitor any treatment induced side-effects and provide justification for any necessary dose modifications or withdrawal of treatment.

Conditions

• Oesophageal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin
DRUG	Capecitabine
DRUG	Carboplatin
DRUG	Paclitaxel
RADIATION	Radiotherapy
PROCEDURE	Surgery	Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-05-01
• Completion: 2016-05-01
• First posted: 2013-05-01
• Last updated: 2014-03-24

Locations

12 sites across 1 country: United Kingdom