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Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases (CAIRO5)

Primary Purpose

Colorectal Cancer, Liver Metastases

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FOLFOX/ FOLFIRI with bevacizumab
FOLFOXIRI with bevacizumab
FOLFOX/ FOLFIRI with panitumumab
Sponsored by
Dutch Colorectal Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Chemotherapy, Anti-EGFR, Liver metastases, R0 R1 liver resection, Resectability of liver, Liver expert panel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological proof of colorectal cancer
  • Initially unresectable metastases confined to the liver according to CT scan, obtained ≤3 weeks prior to registration. Unresectability should be confirmed by the liver expertpanel. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible
  • Known mutation status of RAS and BRAF
  • WHO performance status 0-1 (Karnofsky performance status ≥ 70)
  • Age ≥ 18 years
  • No contraindications for liver surgery
  • In case of primary tumor in situ: tumor should be resectable
  • In case of resected primary tumor: adequate recovery from surgery
  • Adequate organ functions, as determined by normal bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, ≥ 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 5x ULN)
  • Life expectancy > 12 weeks
  • Expected adequacy of follow-up
  • Written informed consent

Exclusion Criteria:

  • Extrahepatic metastases, with the exception of small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases
  • Unresectable primary tumor
  • Serious comorbidity or any other condition preventing the safe administration of study treatment (including both systemic treatment and surgery)
  • Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation
  • Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs
  • Previous systemic treatment for metastatic disease; previous adjuvant treatment is allowed if completed ≥ 6 months prior to randomisation
  • Previous surgery for metastatic disease
  • Previous intolerance of study drugs in the adjuvant setting
  • Pregnant or lactating women
  • Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin, or second primary colorectal cancer.
  • Any concomitant experimental treatment.

Sites / Locations

  • Universitair ziekenhuis AntwerpenRecruiting
  • Wilhelmina Ziekenhuis
  • FlevoziekenhuisRecruiting
  • Ziekenhuis Nij Smellinghe
  • Medisch Centrum Leeuwarden, loc. ZuidRecruiting
  • Antonius ZiekenhuisRecruiting
  • Gelre ZiekenhuisRecruiting
  • Rijnstate ziekenhuisRecruiting
  • Gelderse Vallei
  • Sint Jansdal ZiekenhuisRecruiting
  • Radboud UMCRecruiting
  • Streekziekenhuis Koningin BeatrixRecruiting
  • Atrium Medical CenterRecruiting
  • Maastricht UMC+Recruiting
  • Laurentius ZiekenhuisRecruiting
  • Orbis Medical CenterRecruiting
  • VieCuri Medisch CentrumRecruiting
  • OLVG, locatie OostRecruiting
  • Jeroen Bosch ZiekenhuisRecruiting
  • Bravis ZiekenhuisRecruiting
  • Amphia ZiekenhuisRecruiting
  • Catharina Ziekenhuis
  • St. Anna Ziekenhuis
  • Elkerliek ZiekenhuisRecruiting
  • Bravis ZiekenhuisRecruiting
  • Sint Elisabeth Ziekenhuis
  • TweeSteden ZiekenhuisRecruiting
  • BernhovenRecruiting
  • Maxima Medisch Centrum, loc. VeldhovenRecruiting
  • Medisch Centrum AlkmaarRecruiting
  • Amsterdam UMC, location AMCRecruiting
  • Amsterdam UMC, location VUMCRecruiting
  • Antoni van LeeuwenhoekRecruiting
  • BovenIJ ZiekenhuisRecruiting
  • OLVG, locatie OostRecruiting
  • OLVG, locatie WestRecruiting
  • Rode Kruis Ziekenhuis
  • Spaarne GasthuisRecruiting
  • TergooiRecruiting
  • Spaarne ziekenhuisRecruiting
  • Westfriesgasthuis
  • Waterlandziekenhuis
  • Zaans Medical Center
  • Deventer ZiekenhuisRecruiting
  • Medisch Spectrum TwenteRecruiting
  • Ziekenhuisgroep TwenteRecruiting
  • Isala KliniekenRecruiting
  • Meander Medisch CentrumRecruiting
  • Sint Antonius ZiekenhuisRecruiting
  • Admiraal de Ruyter ziekenhuisRecruiting
  • Bethesda ziekenhuis
  • Reinier de GraafRecruiting
  • HagaziekenhuisRecruiting
  • Medisch Centrum Haaglanden, WesteindeRecruiting
  • Albert Schweitzer ZiekenhuisRecruiting
  • Groene Hart Ziekenhuis
  • LUMCRecruiting
  • Erasmus MC
  • Ikazia Ziekenhuis
  • Maasstad ZiekenhuisRecruiting
  • Sint Franciscus GasthuisRecruiting
  • Franciscus VlietlandRecruiting
  • UMC UtrechtRecruiting
  • Treant zorggroep
  • Martini ZiekenhuisRecruiting
  • UMC GroningenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Arm B: FOLFOXIRI & bevacizumab (inclusion completed)

Arm A: FOLFOX/FOLFIRI & bevacizumab (inclusion completed)

Arm D: FOLFOX/FOLFIRI & panitumumab

Arm C: FOLFOX/ FOLFIRI & bevacizumab

Arm Description

Patients with RAS or BRAF mutated and/or right-sided tumors will receive 5FU, irinotecan, oxaliplatin (FOLFOXIRI) and bevacizumab. Intervention: FOLFOXIRI with bevacizumab

Patients with RAS or BRAF mutated and/or right-sided tumors will receive doublet fluoropyrimidine-containing chemotherapy (FOLFOX or FOLFIRI), plus bevacizumab. Intervention: FOLFOX/FOLFIRI with bevacizumab

Patients with RAS and BRAF wildtype and left-sided tumors will receive doublet fluoropyrimidine-containing chemotherapy (FOLFOX or FOLFIRI), plus panitumumab. Intervention: FOLFOX/FOLFIRI with panitumumab

Patients with RAS and BRAF wildtype and left-sided tumors will receive doublet fluoropyrimidine-containing chemotherapy (FOLFOX or FOLFIRI), plus bevacizumab. Intervention: FOLFOX/FOLFIRI with bevacizumab

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
Time from registration until progression or death whichever comes first

Secondary Outcome Measures

R0/1 secondary resection rate
R0/1 secondary resection rate in each of the 4 study arms upon neoadjuvant treatment with chemotherapy plus targeted therapy.
Median overall survival
From date of randomisation to death or last known to be alive
Response rate
Response according to RECIST 1.1
Toxicity (AE)
Patients will be evaluated for Adverse Events at the start of each treatment cycle according to CTCAE version 4.0.
Pathological complete response rate (pCR)
Pathological complete response rate (pCR) of the resected lesions
Postoperative morbidity
Patients will be evaluated for surgical morbidity during 2 months. Postoperative morbidity will be scored according 'Clavien Dindo Grade'.
Correlation of evaluation by the panel with outcome
CT-scans will be reviewed for liver resectability by expert panel before randomisation and during neo-adjuvant treatment (every 8 weeks).

Full Information

First Posted
June 5, 2014
Last Updated
March 24, 2022
Sponsor
Dutch Colorectal Cancer Group
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1. Study Identification

Unique Protocol Identification Number
NCT02162563
Brief Title
Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases
Acronym
CAIRO5
Official Title
Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases CAIRO5 a Randomized Phase 3 Study of the Dutch Colorectal Cancer Group (DCCG)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2014 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dutch Colorectal Cancer Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Colorectal cancer patients with initially unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and no consensus exist on criteria for resectability. In this study colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by an expert panel according to predefined criteria, will be tested for RAS and BRAF tumor mutation status and selected by location of primary tumor. Patients with RAS or BRAF mutant and/or right sided tumors will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab (schedule 1), and triple chemotherapy (FOLFOXIRI) plus bevacizumab (schedule 2). Patients with RAS AND BRAF wildtype AND left-sided primary tumors will be randomized between doublet chemotherapy (FOLFOX or FOLFIRI) plus either bevacizumab (schedule 1) or panitumumab (schedule 3). Patient imaging will be reviewed for resectability by a central panel, consisting of at least one radiologist and three surgeons every assessment. Central panel review will be performed prior to randomization as well as during treatment, as described in the protocol.
Detailed Description
Patients will be stratified for resectability of liver metastases (potentially resectable versus permanently unresectable), serum lactate dehydrogenase (LDH) (normal versus abnormal), BRAF mutation status (wildtype versus mutated), type of neoadjuvant chemotherapy (FOLFIRI versus FOLFOX) and hospital of registration. Patients with RAS and BRAF wildtype and left-sided primary tumors will be randomised between FOLFOX or FOLFIRI plus either bevacizumab or panitumumab. The choice between FOLFOX or FOLFIRI is to the discretion of the local investigator, however, the treatment is restricted to regimens that are specified in the protocol. Patients with RAS or BRAF mutated and/or right-sided primary tumors will be randomized between FOLFOX/ FOLFIRI (investigator choice) plus bevacizumab or 5FU, irinotecan, oxaliplatin (FOLFOXIRI) plus bevacizumab. Patients will be evaluated every 8 weeks by CT scan for disease status. The assigned systemic treatment should be continued for at least 6 months or earlier in case of resectability, progression of disease, unacceptable toxicity, or patient refusal. If after 6 months the panel concludes that the patient is still not resectable, it is highly unlikely that resectability will be achieved at all. Therefore the chemotherapy regimen may be reconsidered after 6 months of treatment. These patients should continue with the targeted drug in combination with chemotherapy, but the chemotherapy may be altered into a less toxic schedule such as fluoropyrimidine monotherapy. The targeted drug should be continued until progression or unacceptable toxicity. In patients who will become resectable and undergo secondary surgery of liver metastases, the total duration of preoperative and postoperative treatment together should be 6 months, with the chemotherapy schedule being administered according to the assigned treatment arm. However in these patients the targeted drug (bevacizumab or panitumumab) should not be continued after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastases
Keywords
Colorectal cancer, Chemotherapy, Anti-EGFR, Liver metastases, R0 R1 liver resection, Resectability of liver, Liver expert panel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm B: FOLFOXIRI & bevacizumab (inclusion completed)
Arm Type
Experimental
Arm Description
Patients with RAS or BRAF mutated and/or right-sided tumors will receive 5FU, irinotecan, oxaliplatin (FOLFOXIRI) and bevacizumab. Intervention: FOLFOXIRI with bevacizumab
Arm Title
Arm A: FOLFOX/FOLFIRI & bevacizumab (inclusion completed)
Arm Type
Active Comparator
Arm Description
Patients with RAS or BRAF mutated and/or right-sided tumors will receive doublet fluoropyrimidine-containing chemotherapy (FOLFOX or FOLFIRI), plus bevacizumab. Intervention: FOLFOX/FOLFIRI with bevacizumab
Arm Title
Arm D: FOLFOX/FOLFIRI & panitumumab
Arm Type
Experimental
Arm Description
Patients with RAS and BRAF wildtype and left-sided tumors will receive doublet fluoropyrimidine-containing chemotherapy (FOLFOX or FOLFIRI), plus panitumumab. Intervention: FOLFOX/FOLFIRI with panitumumab
Arm Title
Arm C: FOLFOX/ FOLFIRI & bevacizumab
Arm Type
Active Comparator
Arm Description
Patients with RAS and BRAF wildtype and left-sided tumors will receive doublet fluoropyrimidine-containing chemotherapy (FOLFOX or FOLFIRI), plus bevacizumab. Intervention: FOLFOX/FOLFIRI with bevacizumab
Intervention Type
Drug
Intervention Name(s)
FOLFOX/ FOLFIRI with bevacizumab
Other Intervention Name(s)
- bevacizumab, - irinotecan, - leucovorin, - 5-fluorouracil, - oxaliplatin
Intervention Description
FOLFIRI + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by irinotecan 180 mg/m2 i.v. in 60 minutes together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5-fluorouracil 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks FOLFOX6 + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5FU 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
FOLFOXIRI with bevacizumab
Other Intervention Name(s)
- bevacizumab, - irinotecan, - oxaliplatin, - leucovorin, - 5-fluorouracil
Intervention Description
FOLFOXIRI + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by irinotecan 165 mg/m2 i.v. in 60 minutes, followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by continuous infusion of 5-fluorouracil 3200 mg/m2 in 46 hours, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
FOLFOX/ FOLFIRI with panitumumab
Other Intervention Name(s)
- panitumumab, - irinotecan, - leucovorin, - 5-fluorouracil, - oxaliplatin
Intervention Description
FOLFIRI + panitumumab Panitumumab 6 mg/kg i.v. (1st dose in 60 minutes, if well tolerated subsequent doses in 30 minutes), followed by irinotecan 180 mg/m2 i.v. in 60 minutes together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5-fluorouracil 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks FOLFOX6 + panitumumab Panitumumab 6 mg/kg i.v. (1st dose in 60 minutes, if well tolerated subsequent doses in 30 minutes), followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, and bolus 5FU 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Time from registration until progression or death whichever comes first
Time Frame
2 years after last patient in study
Secondary Outcome Measure Information:
Title
R0/1 secondary resection rate
Description
R0/1 secondary resection rate in each of the 4 study arms upon neoadjuvant treatment with chemotherapy plus targeted therapy.
Time Frame
2 years after last patient in study
Title
Median overall survival
Description
From date of randomisation to death or last known to be alive
Time Frame
8 years after last patient in study
Title
Response rate
Description
Response according to RECIST 1.1
Time Frame
2 years after last patient in study
Title
Toxicity (AE)
Description
Patients will be evaluated for Adverse Events at the start of each treatment cycle according to CTCAE version 4.0.
Time Frame
2 years after last patient in study
Title
Pathological complete response rate (pCR)
Description
Pathological complete response rate (pCR) of the resected lesions
Time Frame
2 years after last patient in study
Title
Postoperative morbidity
Description
Patients will be evaluated for surgical morbidity during 2 months. Postoperative morbidity will be scored according 'Clavien Dindo Grade'.
Time Frame
After surgery during two months
Title
Correlation of evaluation by the panel with outcome
Description
CT-scans will be reviewed for liver resectability by expert panel before randomisation and during neo-adjuvant treatment (every 8 weeks).
Time Frame
2 years after last patient in study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological proof of colorectal cancer Initially unresectable metastases confined to the liver according to CT scan, obtained ≤3 weeks prior to registration. Unresectability should be confirmed by the liver expertpanel. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible Known mutation status of RAS and BRAF WHO performance status 0-1 (Karnofsky performance status ≥ 70) Age ≥ 18 years No contraindications for liver surgery In case of primary tumor in situ: tumor should be resectable In case of resected primary tumor: adequate recovery from surgery Adequate organ functions, as determined by normal bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, ≥ 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 5x ULN) Life expectancy > 12 weeks Expected adequacy of follow-up Written informed consent Exclusion Criteria: Extrahepatic metastases, with the exception of small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases Unresectable primary tumor Serious comorbidity or any other condition preventing the safe administration of study treatment (including both systemic treatment and surgery) Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs Previous systemic treatment for metastatic disease; previous adjuvant treatment is allowed if completed ≥ 6 months prior to randomisation Previous surgery for metastatic disease Previous intolerance of study drugs in the adjuvant setting Pregnant or lactating women Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin, or second primary colorectal cancer. Any concomitant experimental treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M.J.G. Bond, Drs.
Phone
+31 6 20 58 16 94
Email
m.j.g.bond-2@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
A.S. Melis
Email
A.Melis@iknl.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.J.A. Punt, Prof. dr.
Organizational Affiliation
University Medical Center, Utrecht NL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R.J. Swijnenburg, Dr.
Organizational Affiliation
Academic Medical Center, Amsterdam NL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair ziekenhuis Antwerpen
City
Antwerpen
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Peeters
Facility Name
Wilhelmina Ziekenhuis
City
Assen
State/Province
Drenthe
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Flevoziekenhuis
City
Almere
State/Province
Flevoland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D.W. Sommeijer, dr.
Email
d.w.sommeijer@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
D.W. Sommeijer, dr.
Facility Name
Ziekenhuis Nij Smellinghe
City
Drachten
State/Province
Friesland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Hovenga, dr.
Email
s.hovenga@nijsmellinghe.nl
First Name & Middle Initial & Last Name & Degree
S. Hovenga, dr.
Facility Name
Medisch Centrum Leeuwarden, loc. Zuid
City
Leeuwarden
State/Province
Friesland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.B. Polée, dr.
Email
m.polee@znb.nl
First Name & Middle Initial & Last Name & Degree
M.B. Polée, dr.
Facility Name
Antonius Ziekenhuis
City
Sneek
State/Province
Friesland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G.J. Veldhuis, dr.
Email
g.veldhuis@antonius-sneek.nl
First Name & Middle Initial & Last Name & Degree
G.J. Veldhuis, dr.
Facility Name
Gelre Ziekenhuis
City
Apeldoorn
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.M. Smit, dr.
Email
j.m.smit@gelre.nl
First Name & Middle Initial & Last Name & Degree
J.M. Smit, dr.
Facility Name
Rijnstate ziekenhuis
City
Arnhem
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Blaisse
Email
rblaisse@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
R Blaisse
Facility Name
Gelderse Vallei
City
Ede
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Sint Jansdal Ziekenhuis
City
Harderwijk
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Temizkan, dr.
Email
m.temizkan@stjansdal.nl
First Name & Middle Initial & Last Name & Degree
M. Temizkan, dr.
Facility Name
Radboud UMC
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. de Wilt, prof.dr.
Email
hans.dewilt@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
H. de Wilt, prof.dr.
Facility Name
Streekziekenhuis Koningin Beatrix
City
Winterswijk
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P.P. Schiphorst, dr.
Email
p.p.schiphorst@skbwinterswijk.nl
First Name & Middle Initial & Last Name & Degree
P.P. Schiphorst, dr.
Facility Name
Atrium Medical Center
City
Heerlen
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F. Warmerdam, dr.
Email
fwm01@atriummc.nl
First Name & Middle Initial & Last Name & Degree
F. Warmerdam, dr.
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R.L.H. Jansen, dr.
Email
rob.jansen@mumc.nl
First Name & Middle Initial & Last Name & Degree
R.L.H. Jansen, dr.
Facility Name
Laurentius Ziekenhuis
City
Roermond
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.O. Boer, dr.
Email
m.denboer@lzr.nl
First Name & Middle Initial & Last Name & Degree
M.O. Boer, dr.
Facility Name
Orbis Medical Center
City
Sittard
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F.L.G. Erdkamp, dr.
Email
f.erdkamp@orbisconcern.nl
First Name & Middle Initial & Last Name & Degree
F.L.G. Erdkamp, dr.
Facility Name
VieCuri Medisch Centrum
City
Venlo
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Vestjens, dr.
Email
hvestjens@viecuri.nl
First Name & Middle Initial & Last Name & Degree
H. Vestjens, dr.
Facility Name
OLVG, locatie Oost
City
Amsterdam
State/Province
Noord Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Gerhards
Email
m.f.gerhards@olvg.nl
First Name & Middle Initial & Last Name & Degree
M Gerhards
Facility Name
Jeroen Bosch Ziekenhuis
City
's Hertogenbosch
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Sinnige, dr.
Email
h.sinnige@jbz.nl
First Name & Middle Initial & Last Name & Degree
H. Sinnige, dr.
Facility Name
Bravis Ziekenhuis
City
Bergen op Zoom
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Troost, dr.
Email
m.troost@bravis.nl
First Name & Middle Initial & Last Name & Degree
M Troost
Facility Name
Amphia Ziekenhuis
City
Breda
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
O.J.L. Loosveld, dr
Email
o.loosveld@amphia.nl
First Name & Middle Initial & Last Name & Degree
O.J.L. Loosveld, dr
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
St. Anna Ziekenhuis
City
Geldrop
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Elkerliek Ziekenhuis
City
Helmond
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Vincent, drs.
Email
j.vincent@elkerliek.nl
First Name & Middle Initial & Last Name & Degree
J. Vincent, drs.
Facility Name
Bravis Ziekenhuis
City
Roosendaal
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H.J. Droogendijk, dr.
Email
hdroogendijk@fzr.nl
First Name & Middle Initial & Last Name & Degree
H.J. Droogendijk, dr.
Facility Name
Sint Elisabeth Ziekenhuis
City
Tilburg
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.M.G.H. Van Riel, dr.
Email
j.riel@elisabeth.nl
First Name & Middle Initial & Last Name & Degree
J.M.G..H. van Riel, dr
Facility Name
TweeSteden Ziekenhuis
City
Tilburg
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Van Alphen
Email
rvalphen@tsz.nl
First Name & Middle Initial & Last Name & Degree
R. van Alphen
Facility Name
Bernhoven
City
Uden
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A.H. Vos, dr.
Email
a.vos@bernhoven.nl
First Name & Middle Initial & Last Name & Degree
A.H. Vos, dr.
Facility Name
Maxima Medisch Centrum, loc. Veldhoven
City
Veldhoven
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R.M.H. Roumen, dr.
Email
r.roumen@mmc.nl
First Name & Middle Initial & Last Name & Degree
R.M.H. Roumen, dr.
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.P. Hendriks, dr.
Email
m.p.hendriks@mca.nl
First Name & Middle Initial & Last Name & Degree
M.P. Hendriks, dr.
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D.W. Sommeijer, Dr.
Email
d.w.sommeijer@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
R.J. Swijnenburg, Dr.
Phone
+31 20 5665570
Email
r.j.swijnenburg@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
D.W. Sommeijer, Dr.
Facility Name
Amsterdam UMC, location VUMC
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H.M.W. Verheul, prof. dr.
Email
h.verheul@vumc.nl
First Name & Middle Initial & Last Name & Degree
H.M.W. Verheul, prof. dr.
Facility Name
Antoni van Leeuwenhoek
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T.M. Ruers, prof. dr.
Email
t.ruers@nki.nl
First Name & Middle Initial & Last Name & Degree
T.M. Ruers, prof. dr.
Facility Name
BovenIJ Ziekenhuis
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S.E. Dohmen, dr.
Email
s.dohmen@bovenij.nl
First Name & Middle Initial & Last Name & Degree
S.E. Dohmen, dr.
Facility Name
OLVG, locatie Oost
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E.D. Kerver, Dr.
Email
e.d.kerver@olvg.nl
First Name & Middle Initial & Last Name & Degree
E.D. Kerver, Dr.
Facility Name
OLVG, locatie West
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A.C. Ogilvie, dr.
Email
a.ogilvie@slaz.nl
First Name & Middle Initial & Last Name & Degree
A.C. Ogilvie, dr.
Facility Name
Rode Kruis Ziekenhuis
City
Beverwijk
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Spaarne Gasthuis
City
Haarlem
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G. de Klerk, dr.
Email
g.de.klerk@kg.nl
First Name & Middle Initial & Last Name & Degree
G. de Klerk, dr.
Facility Name
Tergooi
City
Hilversum
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A.M.T. van der Velde, dr.
Email
avandervelden@tergooi.nl
First Name & Middle Initial & Last Name & Degree
A.M.T. van der Velde, dr.
Facility Name
Spaarne ziekenhuis
City
Hoofddorp
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B. de Valk, dr.
Email
bdevalk@spaarneziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
B. de Valk, dr.
Facility Name
Westfriesgasthuis
City
Hoorn
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Waterlandziekenhuis
City
Purmerend
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.A.C Brakenhoff, dr.
Email
brakenhoff@wlz.nl
First Name & Middle Initial & Last Name & Degree
J.A.C. Brakenhoff, dr.
Facility Name
Zaans Medical Center
City
Zaandam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. van Bochove, dr.
Email
bochove.a@zaansmc.nl
First Name & Middle Initial & Last Name & Degree
A. van Bochove, dr
Facility Name
Deventer Ziekenhuis
City
Deventer
State/Province
Overijssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.S.L. Liem, dr
Email
m.s.l.liem@dz.nl
First Name & Middle Initial & Last Name & Degree
M.S.L. Liem, dr
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.C.J.C. Legdeur, dr.
Email
m.legdeur@mst.nl
First Name & Middle Initial & Last Name & Degree
M.C.J.C. Legdeur, dr.
Facility Name
Ziekenhuisgroep Twente
City
Hengelo
State/Province
Overijssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Hoekstra
Email
r.hoekstra@zgt.nl
First Name & Middle Initial & Last Name & Degree
R. Hoekstra
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.W.B. de Groot, dr.
Email
j.w.b.de.groot@isala.nl
First Name & Middle Initial & Last Name & Degree
J.W.B. de Groot, dr.
Facility Name
Meander Medisch Centrum
City
Amersfoort
State/Province
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C.J. Rodenburg, dr.
Email
c.rodenburg@meandermc.nl
First Name & Middle Initial & Last Name & Degree
C.J. Rodenburg, dr.
Facility Name
Sint Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Los, dr.
Email
m.los@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
M. Los, dr.
Facility Name
Admiraal de Ruyter ziekenhuis
City
Goes
State/Province
Zeeland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Van Halteren
Email
h.vanhalteren@adrz.nl
First Name & Middle Initial & Last Name & Degree
H. Van Halteren
Facility Name
Bethesda ziekenhuis
City
Hoogeveen
State/Province
Zuid Holland
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Reinier de Graaf
City
Delft
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.M.E.M. Bos, dr.
Email
M.Bos@rdgg.nl
First Name & Middle Initial & Last Name & Degree
M.M.E.M. Bos, dr.
Facility Name
Hagaziekenhuis
City
Den Haag
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.E.A. Portielje, dr.
Email
j.portielje@hagaziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
J.E.A. Portielje, dr.
Facility Name
Medisch Centrum Haaglanden, Westeinde
City
Den Haag
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H.H. Helgason, dr.
Email
h.helgason@mchaaglanden.nl
First Name & Middle Initial & Last Name & Degree
H.H. Helgason, dr.
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Trajkovic, Drs.
Email
m.vidakovic@asz.nl
First Name & Middle Initial & Last Name & Degree
M. Trajkovic, Drs.
Facility Name
Groene Hart Ziekenhuis
City
Gouda
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
LUMC
City
Leiden
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H.W. Kapiteijn, dr.
Email
h.w.kapiteijn@lumc.nl
First Name & Middle Initial & Last Name & Degree
H.W. Kapiteijn, dr.
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Terminated
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B. Haberkorn, dr.
Email
haberkornb@maasstadziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
B. Haberkorn, dr.
Facility Name
Sint Franciscus Gasthuis
City
Rotterdam
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A.P. Hamberg, dr.
Email
p.hamberg@franciscus.nl
First Name & Middle Initial & Last Name & Degree
A.P. Hamberg, dr.
Facility Name
Franciscus Vlietland
City
Schiedam
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.B. Ruit, dr.
Email
j.ruit@franciscus.nl
First Name & Middle Initial & Last Name & Degree
J.B. Ruit, dr.
Facility Name
UMC Utrecht
City
Utrecht
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Koopman, dr.
Email
m.koopman-6@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
M. Koopman, dr.
Facility Name
Treant zorggroep
City
Emmen
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R.S. de Jong, dr.
Email
r.s.dejong@mzh.nl
First Name & Middle Initial & Last Name & Degree
R.S. de Jong, dr.
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G.A.P. Hospers, dr
Email
g.a.p.hospers@umcg.nl
First Name & Middle Initial & Last Name & Degree
G.A.P. Hospers, dr.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be stored in the international ARCAD database which is available to other researchers.
IPD Sharing Time Frame
As of 2023
IPD Sharing Access Criteria
Member of ARCAD
Citations:
PubMed Identifier
35522139
Citation
Wesdorp NJ, Kemna R, Bolhuis K, van Waesberghe JHTM, Nota IMGC, Struik F, Oulad Abdennabi I, Phoa SSKS, van Dieren S, van Amerongen MJ, Chapelle T, Dejong CHC, Engelbrecht MRW, Gerhards MF, Grunhagen D, van Gulik TM, Hermans JJ, de Jong KP, Klaase JM, Liem MSL, van Lienden KP, Molenaar IQ, Patijn GA, Rijken AM, Ruers TM, Verhoef C, de Wilt JHW, Swijnenburg RJ, Punt CJA, Huiskens J, Stoker J, Kazemier G; Dutch Colorectal Liver Expert Panel. Interobserver Variability in CT-based Morphologic Tumor Response Assessment of Colorectal Liver Metastases. Radiol Imaging Cancer. 2022 May;4(3):e210105. doi: 10.1148/rycan.210105.
Results Reference
derived
PubMed Identifier
25943574
Citation
Huiskens J, van Gulik TM, van Lienden KP, Engelbrecht MR, Meijer GA, van Grieken NC, Schriek J, Keijser A, Mol L, Molenaar IQ, Verhoef C, de Jong KP, Dejong KH, Kazemier G, Ruers TM, de Wilt JH, van Tinteren H, Punt CJ. Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases, a study protocol of the randomised phase 3 CAIRO5 study of the Dutch Colorectal Cancer Group (DCCG). BMC Cancer. 2015 May 6;15:365. doi: 10.1186/s12885-015-1323-9.
Results Reference
derived
Links:
URL
http://www.dccg.nl
Description
Website Dutch Colorectal Cancer Group

Learn more about this trial

Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases

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