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A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer (AGENT)

Primary Purpose

Colo-rectal Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Arfolitixorin
Leucovorin
Sponsored by
Isofol Medical AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colo-rectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Colorectal adenocarcinoma verified by biopsy.
  2. Availability of biopsy material, from the primary tumor or metastasis, allowing for analysis of tumor gene expression.
  3. Non-resectable metastatic CRC planned for first line therapy with 5-FU, oxaliplatin, and bevacizumab.
  4. Evaluable disease with at least one measurable lesion of metastatic disease (≥10 mm in longest diameter on axial image on CT-scan or alternatively MRI with <5 mm reconstruction interval) obtained within 28 days of randomization.
  5. Life expectancy of more than 4 months.
  6. ECOG performance status 0 or 1.
  7. Hemoglobin (Hb) > 100 g/L, Absolute neutrophil count (ANC) > 1.5x109/L. Thrombocytes > 100x109/L.
  8. Creatinine clearance > 50 mL/min, Total bilirubin < 1.5 x ULN, AST and ALT < 3 x ULN (and < 5 x ULN in case of liver metastases).
  9. Male or female ≥18 years of age.
  10. Female patients of childbearing potential must have a negative urine pregnancy test and use adequate contraceptive measures . Male patients must use adequate contraceptive measures .
  11. Voluntarily signed informed consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

Exclusion Criteria:

  1. Malignant tumors other than colorectal adenocarcinomas (current or within the previous five years), with the exception for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
  2. Less than 6 months between randomization and completion of the last anti-cancer treatment (chemotherapy/radiotherapy/immunotherapy/surgery, etc.). (NB: Rectal cancer treatment shorter than 8 weeks of chemo/radiation therapy is allowed.)
  3. Confirmation of progressive disease within 6 months after completion of prior anti-cancer treatment.
  4. Indication for any metastatic Colo-rectal Cancer (mCRC) surgery or anti-cancer treatment other than study treatment.
  5. Prior treatment with arfolitixorin.
  6. Indication for treatment with a 5-FU analogue, or 5-FU for a condition other than mCRC.
  7. Known Dihydropyrimidine Dehydrogenase Deficiency (DPD) deficiency.
  8. Known or suspected central nervous system (CNS) metastases.
  9. Unresolved bowel obstruction, uncontrolled Crohn's disease, or ulcerative colitis.
  10. History of cardiac disease with a New York Heart Association Class II or greater, congestive heart failure, myocardial infarction, or unstable angina at any time during the 6 months prior to randomization, or serious arrhythmias requiring medication for treatment.
  11. Current CTCAE ≥ grade 3 diarrhea.
  12. Current chronic infection or uncontrolled serious illness causing immunodeficiency.
  13. Known or suspected hypersensitivity or intolerance to arfolitixorin, LV, 5-FU, oxaliplatin, or bevacizumab.
  14. Breastfeeding patients.
  15. Patient who received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug, prior to randomization.
  16. Patient with serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  17. Ongoing drug or alcohol abuse, as deemed by the Investigator.
  18. Any condition that, in the opinion of the Investigator, could compromise the patient's safety or adherence to the study protocol.
  19. Involvement, or related to people involved in the planning or conduct of the study (applies to both Isofol Medical AB (publ) staff and staff at the study site)

Sites / Locations

  • 840-24 - Banner Gateway Medical Center
  • 840-01 - University of Southern California
  • 840-15 - HOAG Memorial Hospital
  • 840-13 - UCH-MHS d/b/a Memorial Health System
  • 840-34 - Banner MD Anderson Cancer Center
  • 840-32 - University of Miami
  • 840-08 - Pinellas Hematology Oncology
  • 840-30 - Joliet Oncology-Hematology Associates
  • 840-06 - Cancer Center of Kansas
  • 840-29 - Ashland-Bellefonte Cancer Center
  • 840-19 - University of Louisville Research Foundation Inc. (ULRF)
  • 840-14 - University of Michigan Cancer Center
  • 840-04 - St. Vincent Frontier Cancer Center
  • 840-12 - Rutgers Cancer Institute of New Jersey
  • 840-22 - University of Oklahoma Stephenson Cancer Center
  • 840-10 - Oregon Health and Science University-Knight Cancer Institute
  • 840-27 - Charleston Hematology Oncology Associates
  • 840-02 - The University of Texas Health Science Center
  • 036-10 - Border Medical Oncology Research Unit
  • 036-02 - Chris O'Brien Lifehouse
  • 036-03 - Westmead Hospital
  • 036-09 - Southern Medical Day Care Center
  • 036-04 - Peninsula Health - Frankston Hospital
  • 036-01 - Western Health - Sunshine Hospital
  • 036-07 - Northern Health - Epping Hospital
  • 036-05 - Monash Health
  • 040-02 - Klinikum Klagenfurt am Wörthersee
  • 040-06 - Ordensklinikum Linz GmbH - Barmherzige Schwestern
  • 040-03 - Landeskrankenhaus
  • 040-04 - Landesklinikum Wiener Neustadt
  • 040-01 - Allgemeines Krankenhaus der Stadt Wien
  • 040-05 - Wilhelminenspital
  • 124-03 - William Osler Health System - Brampton Civi Hospital
  • 124-10 - Thunder Bay Regional Health Research Institute
  • 124-07 - Sunnybrook Research Institute
  • 124-04 - CISSS de l'Outaouais - Hôpital de Gatineau
  • 124-11 - CISSS de Chaudière-Appalaches
  • 124-01 - Montreal University Health Center
  • 124-02 - Hôpital de la Cité-de-la-Santé
  • 124-08 - Hôpital Maisonneuve Rosemont
  • 124-06 - Jewish General Hospital
  • 124-05 - Ottawa Hospital Research Institute
  • 250-07 - Hôpital Henri Mondor
  • 250-06 - Centre Georges Francois Leclerc
  • 250-01 - Institute Hospitalier Franco-Britannique
  • 250-09 - Hopital Privé Jean Mermoz
  • 250-08 - Hôpital Européen
  • 250-03 - Hôpital Paris Saint Joseph
  • 250-02 - Hôpital Saint-Antoine
  • 250-04 - Polyclinique Francheville
  • 250-05 - Clinique Sainte Anne
  • 276-12 - Charité - Universitätsmedizin Berlin
  • 276-02 - Universitätsklinikum Carl Gustav Carus
  • 276-03 - Krankenhaus Nordwest GmbH
  • 276-10 - Universitärers Cancer Center Hamburg (UCCH)
  • 276-11 - Klinikum Kassel GmbH
  • 276-04 - MVZ Mitte - Onkologische Schwerpunktpraxis
  • 276-13 - Universitäres Krebszentrum Leipzig (UCCL)
  • 276-07 - Philipps-Universität Marburg
  • 276-08 - Carl von Basedow Klinikum Saalekrei GmbH
  • 276-01 - Klinikum der Universität München - Campus Grosshadern
  • 276-09 - Klinikum Nürnberg Nord
  • 276-05 - Kliniken Nordoberpfalz AG
  • 300-04 - 251 Airforce Hospital
  • 300-01 - Aretaieo Hospital
  • 300-02 - University General Hospital Attikon
  • 300-03 - Metropolitan General Hospital
  • 300-05 - Metropolitan General SA
  • 300-06 - University General Hospital of Larissa
  • 392-10 - Aichi Cancer Center
  • 392-01 - National Cancer Center Hospital East
  • 392-09 - National Hospital Organization Shikoku Cancer Center
  • 392-07 - Gifu University Hospital
  • 392-12 - Saitama Medical University International Medical Center
  • 392-05 - University of Tsukuba Hospital
  • 392-15 - Kagawa University Hospital
  • 392-08 - St.Marianna University School of Medicine Hospital
  • 392-11 - National Hospital Organization Osaka National Hospital
  • 392-13 - Osaka General Medical Center
  • 392-14 - Kansai Medical University Hospital
  • 392-04 - Saitama Cancer Center
  • 392-03 - Hokkaido University Hospital
  • 392-02 - Shizuoka Cancer Center
  • 392-06 - National Cancer Center Hospital
  • 724-03 - Instituto Oncologico Baselga - Hospital Quiron
  • 724-07 - Hospital del la Santa Creu i Sant Pau
  • 724-01 - Vall d'Hebron Institute of Oncology
  • 724-06 - Hospital Universitario Reina Sofia
  • 724-04 - Hospital Unviersitario 12 de Octubre
  • 724-09 - Hospital Universitario HM Sanchinarro
  • 724-02 - Hospital Regional Universitario Carlos Haya
  • 724-05 - Hospital Universitario Virgen del Rocío
  • 752-02 - Södersjukhuset
  • 752-01 - Akademiska Sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab

mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab

Outcomes

Primary Outcome Measures

Overall response rate
Best ORR, defined as the best response recorded from the start of the study treatment until the end of treatment.

Secondary Outcome Measures

Progression free survival
PFS, defined as the time from randomization to first occurrence of tumor progression based on CT-scans/MRIs.
Duration of response
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

Full Information

First Posted
November 19, 2018
Last Updated
March 29, 2022
Sponsor
Isofol Medical AB
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1. Study Identification

Unique Protocol Identification Number
NCT03750786
Brief Title
A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer
Acronym
AGENT
Official Title
A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isofol Medical AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Arfolitixorin
Intervention Description
Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
Primary Outcome Measure Information:
Title
Overall response rate
Description
Best ORR, defined as the best response recorded from the start of the study treatment until the end of treatment.
Time Frame
Until disease progression, an average of ten months
Secondary Outcome Measure Information:
Title
Progression free survival
Description
PFS, defined as the time from randomization to first occurrence of tumor progression based on CT-scans/MRIs.
Time Frame
Until disease progression, an average of ten months
Title
Duration of response
Description
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
Time Frame
Until disease progression, an average of ten months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Colorectal adenocarcinoma verified by biopsy. Availability of biopsy material, from the primary tumor or metastasis, allowing for analysis of tumor gene expression. Non-resectable metastatic CRC planned for first line therapy with 5-FU, oxaliplatin, and bevacizumab. Evaluable disease with at least one measurable lesion of metastatic disease (≥10 mm in longest diameter on axial image on CT-scan or alternatively MRI with <5 mm reconstruction interval) obtained within 28 days of randomization. Life expectancy of more than 4 months. ECOG performance status 0 or 1. Hemoglobin (Hb) > 100 g/L, Absolute neutrophil count (ANC) > 1.5x109/L. Thrombocytes > 100x109/L. Creatinine clearance > 50 mL/min, Total bilirubin < 1.5 x ULN, AST and ALT < 3 x ULN (and < 5 x ULN in case of liver metastases). Male or female ≥18 years of age. Female patients of childbearing potential must have a negative urine pregnancy test and use adequate contraceptive measures . Male patients must use adequate contraceptive measures . Voluntarily signed informed consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. Exclusion Criteria: Malignant tumors other than colorectal adenocarcinomas (current or within the previous five years), with the exception for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix. Less than 6 months between randomization and completion of the last anti-cancer treatment (chemotherapy/radiotherapy/immunotherapy/surgery, etc.). (NB: Rectal cancer treatment shorter than 8 weeks of chemo/radiation therapy is allowed.) Confirmation of progressive disease within 6 months after completion of prior anti-cancer treatment. Indication for any metastatic Colo-rectal Cancer (mCRC) surgery or anti-cancer treatment other than study treatment. Prior treatment with arfolitixorin. Indication for treatment with a 5-FU analogue, or 5-FU for a condition other than mCRC. Known Dihydropyrimidine Dehydrogenase Deficiency (DPD) deficiency. Known or suspected central nervous system (CNS) metastases. Unresolved bowel obstruction, uncontrolled Crohn's disease, or ulcerative colitis. History of cardiac disease with a New York Heart Association Class II or greater, congestive heart failure, myocardial infarction, or unstable angina at any time during the 6 months prior to randomization, or serious arrhythmias requiring medication for treatment. Current CTCAE ≥ grade 3 diarrhea. Current chronic infection or uncontrolled serious illness causing immunodeficiency. Known or suspected hypersensitivity or intolerance to arfolitixorin, LV, 5-FU, oxaliplatin, or bevacizumab. Breastfeeding patients. Patient who received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug, prior to randomization. Patient with serious medical or psychiatric illness likely to interfere with participation in this clinical study. Ongoing drug or alcohol abuse, as deemed by the Investigator. Any condition that, in the opinion of the Investigator, could compromise the patient's safety or adherence to the study protocol. Involvement, or related to people involved in the planning or conduct of the study (applies to both Isofol Medical AB (publ) staff and staff at the study site)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Tabernero, Prof.
Organizational Affiliation
Vall d'Hebron Institute of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
840-24 - Banner Gateway Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
840-01 - University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
91001
Country
United States
Facility Name
840-15 - HOAG Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
840-13 - UCH-MHS d/b/a Memorial Health System
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
840-34 - Banner MD Anderson Cancer Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
840-32 - University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
840-08 - Pinellas Hematology Oncology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
840-30 - Joliet Oncology-Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
840-06 - Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
840-29 - Ashland-Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
840-19 - University of Louisville Research Foundation Inc. (ULRF)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1798
Country
United States
Facility Name
840-14 - University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
840-04 - St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
840-12 - Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
840-22 - University of Oklahoma Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
840-10 - Oregon Health and Science University-Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
840-27 - Charleston Hematology Oncology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
840-02 - The University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
036-10 - Border Medical Oncology Research Unit
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
036-02 - Chris O'Brien Lifehouse
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
036-03 - Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
036-09 - Southern Medical Day Care Center
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
036-04 - Peninsula Health - Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
036-01 - Western Health - Sunshine Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
036-07 - Northern Health - Epping Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3076
Country
Australia
Facility Name
036-05 - Monash Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
040-02 - Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
040-06 - Ordensklinikum Linz GmbH - Barmherzige Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
040-03 - Landeskrankenhaus
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
040-04 - Landesklinikum Wiener Neustadt
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Facility Name
040-01 - Allgemeines Krankenhaus der Stadt Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
040-05 - Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
124-03 - William Osler Health System - Brampton Civi Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
124-10 - Thunder Bay Regional Health Research Institute
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
124-07 - Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
124-04 - CISSS de l'Outaouais - Hôpital de Gatineau
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8V 2L4
Country
Canada
Facility Name
124-11 - CISSS de Chaudière-Appalaches
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
124-01 - Montreal University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
124-02 - Hôpital de la Cité-de-la-Santé
City
Laval
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
124-08 - Hôpital Maisonneuve Rosemont
City
Montréal
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
124-06 - Jewish General Hospital
City
Montréal
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
124-05 - Ottawa Hospital Research Institute
City
Ottawa
ZIP/Postal Code
KIH8L6
Country
Canada
Facility Name
250-07 - Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
250-06 - Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
250-01 - Institute Hospitalier Franco-Britannique
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
250-09 - Hopital Privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
250-08 - Hôpital Européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
250-03 - Hôpital Paris Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
250-02 - Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
250-04 - Polyclinique Francheville
City
Périgueux
ZIP/Postal Code
24000
Country
France
Facility Name
250-05 - Clinique Sainte Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
276-12 - Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
276-02 - Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
276-03 - Krankenhaus Nordwest GmbH
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
276-10 - Universitärers Cancer Center Hamburg (UCCH)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
276-11 - Klinikum Kassel GmbH
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
276-04 - MVZ Mitte - Onkologische Schwerpunktpraxis
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
276-13 - Universitäres Krebszentrum Leipzig (UCCL)
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
276-07 - Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35032
Country
Germany
Facility Name
276-08 - Carl von Basedow Klinikum Saalekrei GmbH
City
Merseburg
ZIP/Postal Code
06217
Country
Germany
Facility Name
276-01 - Klinikum der Universität München - Campus Grosshadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
276-09 - Klinikum Nürnberg Nord
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
276-05 - Kliniken Nordoberpfalz AG
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
300-04 - 251 Airforce Hospital
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
300-01 - Aretaieo Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
300-02 - University General Hospital Attikon
City
Athens
ZIP/Postal Code
15562
Country
Greece
Facility Name
300-03 - Metropolitan General Hospital
City
Athens
ZIP/Postal Code
15562
Country
Greece
Facility Name
300-05 - Metropolitan General SA
City
Athen
ZIP/Postal Code
15562
Country
Greece
Facility Name
300-06 - University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
392-10 - Aichi Cancer Center
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
392-01 - National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
392-09 - National Hospital Organization Shikoku Cancer Center
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
392-07 - Gifu University Hospital
City
Gifu City
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
392-12 - Saitama Medical University International Medical Center
City
Hidaka City
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
392-05 - University of Tsukuba Hospital
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
392-15 - Kagawa University Hospital
City
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
392-08 - St.Marianna University School of Medicine Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
392-11 - National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
392-13 - Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
392-14 - Kansai Medical University Hospital
City
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
392-04 - Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
392-03 - Hokkaido University Hospital
City
Sapporo Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
392-02 - Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
392-06 - National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
724-03 - Instituto Oncologico Baselga - Hospital Quiron
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
724-07 - Hospital del la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
724-01 - Vall d'Hebron Institute of Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
724-06 - Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
724-04 - Hospital Unviersitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
724-09 - Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
724-02 - Hospital Regional Universitario Carlos Haya
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
724-05 - Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
752-02 - Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
752-01 - Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

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