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Trial Summary

The purpose of this phase III study is to determine whether regorafenib is effective in prolonging survival in patients with advanced gastro-oesophageal carcinoma.

Acronym:

INTEGRATE II

ACTRN/NCT /ethics:

ACTRN12616000420448

Scientific title:

A Randomised Phase III Double-Blind Placebo-Controlled Study of regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

Sponsor / Cooperative group:

The Australasian Gastro-Intestinal Trials Group (AGITG)

Trial & Patient Characteristics

Cancer TypeStomach & Oesophageal
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2016-11-01
Anticipated End Date2021-12-01

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlex Scott-Hoy
Emailalex.scott-hoy@sa.gov.au
Phone08 8204 4830
Principal InvestigatorProfessor Chris Karapetis
Recruitment StatusRecruiting
HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6140
Principal InvestigatorProfessor Tim Price
Recruitment StatusRecruiting
HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Caroline Bampton
Recruitment StatusRecruiting