Radiotherapy & Olaparib in COmbination for Carcinoma of the Oesophagus

Sponsor
The Christie NHS Foundation Trust
Study ID
NCT01460888
Phase
PHASE1
Status
Unknown

Conditions

  • Carcinoma of the Oesophagus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    25mg tablets, oral. Commenced 3 days prior to radiotherapy and continuing until the last day of radiotherapy (36 days in total).
  • Radical external beam radiotherapy, 50Gy in 25 fractions — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2013
Status verified
Dec 2011
Primary completion
Jul 31, 2015
Completion
Aug 31, 2018

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OLA-0 (de-escalation dose)
    25mg olaparib twice daily + radiotherapy (50Gy in 25 fractions)
  • Experimental: OLA-1
    50mg olaparib twice daily + radiotherapy (50Gy in 25 fractions)
  • Experimental: OLA-2
    100mg olaparib twice daily + radiotherapy (50Gy in 25 fractions)
  • Experimental: OLA-3
    200mg olaparib twice daily + radiotherapy (50Gy in 25 fractions)
  • Active Comparator: RT alone

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of olaparib in combination with radical radiotherapy in patients with oesophageal cancer [ Time Frame: 3 months post treatment ]

Central Contacts