stop_circleTerminated/Withdrawn

Colorectal Neoplasms

Colorectal Cancer Treated with Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo‑controlled Phase-III STudy

Trial purpose

To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
25
Trial Dates
December 2013 - August 2016
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Haifa, 3109601, Israel
Completed
Tel Aviv, 64239, Israel
Completed
Ramat Gan, 52482, Israel
Terminated
Oldenburg, 26133, Germany
Terminated
München, 81377, Germany
Terminated
Frankfurt, 60590, Germany
Terminated
Berlin, 12200, Germany
Completed
Pisa, 56126, Italy
Terminated
Milano, 20089, Italy
Terminated
Roma, 00189, Italy
Terminated
Foggia, 71013, Italy
Completed
Napoli, 80131, Italy
Completed
Milano, 20133, Italy
Terminated
Reggio Emilia, 42123, Italy
Terminated
Udine, 33100, Italy
Terminated
Napoli, 80131, Italy
Terminated
Firenze, 50134, Italy
Terminated
Bentleigh East, 3165, Australia
Terminated
East Melbourne, 3002, Australia
Completed
Liverpool, 2170, Australia
Terminated
Malvern, 3144, Australia
Terminated
Belo Horizonte, 30110-090, Brazil
Terminated
São José do Rio Preto, Brazil
Terminated
Porto Alegre, Brazil
Terminated
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Terminated
London, WC1E 6BT, United Kingdom
Completed
Bristol, BS2 8ED, United Kingdom
Completed
Córdoba, 14004, Spain
Completed
Valencia, 46009, Spain
Terminated
Madrid, 28007, Spain
Completed
Madrid, 28034, Spain
Completed
Alicante, 03010, Spain
Terminated
Madrid, 28040, Spain
Terminated
Laguna Hills, 92653, United States
Terminated
Seattle, 98101, United States
Terminated
Buffalo, 14263-0001, United States
Terminated
Omaha, 68106, United States
Completed
Chattanooga, 37421, United States
Completed
LYON Cedex 08, 69373, France
Terminated
Marseille, 13385, France
Terminated
POITIERS CEDEX, 86021, France
Terminated
Clermont-Ferrand, 63000, France
Terminated
PARIS, 75651, France
Terminated
TOURS, 37044, France
Terminated
Bordeaux, 33076, France
Terminated
BREST, 29285, France
Terminated
LEUVEN, 3000, Belgium
Terminated
EDEGEM, 2650, Belgium
Terminated
LIEGE, 4000, Belgium
Terminated
New Orleans, 70121, United States
Completed
Rochester, 55905, United States
Completed
New Haven, 06520-8064, United States
Terminated
Detroit, 48202, United States
Terminated
Los Angeles, 90089, United States
Completed
Richmond, 23298-0037, United States
Completed
New York, 10021, United States
Terminated
Philadelphia, 19104, United States
Terminated
Baltimore, 21201-1595, United States
Terminated
New Brunswick, 08903-2681, United States
Terminated
Syracuse, 13210, United States
Terminated
Duke University Medical CenterDurham, 27710, United States
Terminated
Los Angeles, 90095, United States
Terminated
Porto, 4200-072, Portugal
Terminated
Almada, 2801-951, Portugal
Terminated
Santa Maria da Feira, 4520-531, Portugal
Terminated
Seattle, 98109, United States
Terminated
Los Angeles, 90033, United States
Terminated
Dallas, 75390, United States
Terminated
Kirkland, 98034, United States
Terminated
Dallas, 75390, United States
Terminated
Toronto, M5G 1X8, Canada
Terminated
Montreal, H2W 1S6, Canada
Terminated
Edmonton, T6G 1Z2, Canada
Terminated
London, SW3 6JJ, United Kingdom
Terminated
Sherbrooke, J1H 5N4, Canada
Terminated
Kashiwa, 277-8577, Japan
Completed
Koto-ku, 135-8550, Japan
Terminated
Mitaka, 181-8611, Japan
Terminated
Minato-ku, 105-8471, Japan
Completed
Shinagawa, 142-8666, Japan
Terminated
Shinjuku-ku, 160-8582, Japan
Terminated
Yokohama, 241-8515, Japan
Terminated
Shimotsuke, 329-0498, Japan
Completed
Kasama, 309-1793, Japan
Completed
Sunto, 411-8777, Japan
Completed
Suita, 565-0871, Japan
Terminated
Takatsuki, 569-8686, Japan
Completed
Kobe, 650-0047, Japan
Terminated
Fukuoka, 812-8582, Japan
Terminated
Fukuoka, 811-1395, Japan
Terminated
Sapporo, 060-8648, Japan
Terminated
Sapporo, 060-0004, Japan
Terminated
Brescia, 25124, Italy
Terminated
Fukuoka, 810-8563, Japan
Completed
Akashi, 673-8558, Japan
Completed
Sapporo, 006-8555, Japan
Completed
Amagasaki, 660-8511, Japan
Completed
Barcelona, 08036, Spain
Terminated
Milano, 20141, Italy
Terminated
Germantown, 38138, United States
Completed
Badajoz, 06080, Spain
Terminated
Valencia, 46013, Spain
Terminated
São Paulo, 01246-000, Brazil
Terminated
Guangzhou, 510060, China
Terminated
Beijing, 100071, China
Terminated
Xi'an, 710032, China
Terminated
Beijing, 100142, China
Terminated
Hangzhou, 310016, China
Completed
Hangzhou, 310009, China
Terminated
Harbin, China
Terminated
Wuhan, 430033, China
Terminated
Shanghai, 200030, China
Terminated
VILLEJUIF, 94800, France
Terminated
Xi'an, 710038, China
Terminated
Shanghai, 200032, China
Terminated
Beijing, 100730, China
Terminated
Changsha, 410008, China
Terminated
Kunming, 650118, China
Terminated
Shanghai, 200127, China
Terminated
Guangzhou, 510655, China
Terminated
Fujian Medical University Union HospitalFuzhou, 350001, China
Terminated
Mainz, 55131, Germany
Terminated
Beijing, 100021, China

Primary Outcome

  • Disease Free Survival (DFS) as assessed by the investigator
    Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.
    date_rangeTime Frame:
    From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented.
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall survival (OS)
    Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive.
    date_rangeTime Frame:
    Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn.
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients with Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2