A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer
- Registration Number
- NCT02773524
- Lead Sponsor
- Australasian Gastro-Intestinal Trials Group
- Brief Summary
A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)
- Detailed Description
Purpose:
The purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.
Who is it for:
You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.
Trial Details:
Participants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression Regorafenib Regorafenib Regorafenib 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression
- Primary Outcome Measures
Name Time Method Overall Survival From time of patient randomisation until date last known alive (up to 12 months following end of treatment). The interval from the date of randomisation to date of death from any cause, or the date last known alive.
- Secondary Outcome Measures
Name Time Method Progression Free Survival From time of patient randomisation until first evidence of disease progression or death (up to 12 months following randomisation). The interval from the date of randomisation to the date of first evidence of disease progression or death, whichever occurs first.
Evaluation of health states experienced by participants From time of commencement of treatment until first evidence of disease progression (up to 12 months following commencement of treatment). Questionnaire used to assess quality of life
Objective Tumour Response Rate From time of patient randomisation until evidence of complete or partial response (up to 12 months following randomisation). The OTRR will be calculated by summing the number of participants in a given arm that are assessed as having a complete or partial response (as per RECIST criteria), and dividing this by the total number of participants in the corresponding arm of the analysis set.
Rates of Adverse Events From time dose of study treatment until 30 days after last dose of study treatment A descriptive analysis of the adverse events (AE) data will be prepared for participants in the safety population. The number and percentage of participants who experience AEs will be tabulated according to CTCAE term/category, grade, and seriousness.
Trial Locations
- Locations (60)
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Bon Secours Cancer Institute
🇺🇸Midlothian, Virginia, United States
Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
Border Medical Oncology
🇦🇺Albury, New South Wales, Australia
Monash Medical Centre
🇦🇺Clayton, New South Wales, Australia
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
St Vincent's Public Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Newcastle Private Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Port Macquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
Royal North Shore Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Ballarat Oncology and Haematology Services
🇦🇺Wendouree, New South Wales, Australia
The Tweed Hospital
🇦🇺Tweed Heads, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
The Townsville Hospital
🇦🇺Douglas, Queensland, Australia
Sunshine Coast University Hospital
🇦🇺Sunshine Coast, Queensland, Australia
Ashford Cancer Centre Research
🇦🇺Ashford, South Australia, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
PEI Cancer Treatment Centre, Queen Elizabeth Hospital
🇨🇦Charlottetown, Canada
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Ottawa Hospital Research Institute
🇨🇦Ottawa, Canada
University Health Network Princess Margaret Cancer Centre
🇨🇦Toronto, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Canada
The Research Institute of the McGill University Health Centre
🇨🇦Québec, Canada
National Cancer Centre Hospital East
🇯🇵Chiba, Kashiwa, Japan
Allan Blair Cancer Centre
🇨🇦Regina, Canada
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Hokkaido University Hospital
🇯🇵Sapporo, Kita, Japan
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea - Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea - Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System - Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Auckland Hospital
🇳🇿Auckland, New Zealand
National Cheng Kung University Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital (NTUH)
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital (TPVGH)
🇨🇳Taipei, Taiwan
USC Norris
🇺🇸Los Angeles, California, United States
Carle Cancer Center NCI Community Oncology Research Program
🇺🇸Urbana, Illinois, United States
Coffs Harbour Health Campus
🇦🇺Coffs Harbour, New South Wales, Australia
Royal Brisbane and Womens Hospital
🇦🇺Herston, Queensland, Australia
St John of God Hospital Subiaco
🇦🇺Subiaco, Western Australia, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
China Medical University Hospital
🇨🇳Taichung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Yonsei University Health System - Severance Hospital
🇰🇷Seoul, Korea, Republic of
Royal Darwin Hospital
🇦🇺Tiwi, Northern Territory, Australia
Queen Elizabeth II Health Sciences Centre
🇨🇦Nova Scotia, Canada