NCT01460888

Radiotherapy & Olaparib in COmbination for Carcinoma of the Oesophagus

Radiotherapy & Olaparib in COmbination for Carcinoma of the Oesophagus. A Phase I Trial.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of olaparib in combination with radical radiotherapy in patients with oesophageal cancer who are unsuitable for platinum containing chemotherapy.

Conditions

• Carcinoma of the Oesophagus

Interventions

Type	Name	Description
DRUG	Olaparib	25mg tablets, oral. Commenced 3 days prior to radiotherapy and continuing until the last day of radiotherapy (36 days in total).
RADIATION	Radical external beam radiotherapy, 50Gy in 25 fractions	Radiotherapy to the oesophageal carcinoma. For patients receiving olaparib this is delivered as 50Gy in 25 daily fractions for 5 weeks (Monday-Friday only). For patients in the comparator arm (RT only) other total doses/ fractionation are permitted, according to local policy/ best standard care.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-07-01
• Completion: 2018-08-01
• First posted: 2011-10-27
• Last updated: 2013-08-19

Locations

2 sites across 1 country: United Kingdom