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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1084-012 | Other Identifier | MSD | |
| KANDLELIT-012 | Other Identifier | MSD | |
| 2024-517232-22-00 | Registry Identifier | EU CT | |
| U1111-1311-8311 | Registry Identifier | UTN | |
| jRCT2031250265 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
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Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.
Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies.
The goals of this study are to learn:
This study will have 2 parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calderasib + Cetuximab + mFOLFOX6 | Experimental | Participants will receive calderasib orally, cetuximab per label every 2 weeks (Q2W), and mFOLFOX6 chemotherapy: oxaliplatin per label every 2 weeks (Q2W), leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Treatment will continue until criteria for discontinuation is met. |
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| mFOLFOX6 | Active Comparator | Participants will receive mFOLFOX6 chemotherapy: oxaliplatin per label Q2W, leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Participants may also receive bevacizumab or bevacizumab biosimilar Q2W at the investigator's discretion. Treatment will continue until criteria for discontinuation is met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calderasib | Drug | Oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose-Limiting Toxicity (DLT) | A DLT is defined as the occurrence of protocol-specified toxicities if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration. | Up to approximately 28 days |
| Part 1: Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 44 months |
| Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 44 months |
| Progression Free Survival (PFS) | PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. | Up to approximately 44 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as a confirmed complete response (CR: the disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). The percentage of participants who experience CR or PR as assessed by BICR will be presented. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Hematology Oncology Medical Group ( Site 0084) | Recruiting | Los Angeles | California | 90017 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Oxaliplatin | Drug | Per label |
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| Leucovorin/levofolinate calcium | Drug | Per label |
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| 5-Fluorouracil | Drug | Per label |
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| Cetuximab | Biological | Per label |
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| Bevacizumab | Drug | Per label |
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| Bevacizumab biosimilar | Drug | Per label |
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| Up to approximately 3 years |
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 5 years |
| Duration of Response (DOR) | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. | Up to approximately 4 years |
| Part 2: Number of Participants with an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 5 years |
| Part 2: Number of Participants who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 5 years |
| Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented. A higher score indicates a better outcome. | Baseline and up to approximately 5 years |
| Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate better physical functioning. The change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score will be presented. | Baseline and up to approximately 5 years |
| Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be presented. | Baseline and up to approximately 5 years |
| Change from Baseline in the EORTC-QLQ-C30 Appetite Loss (Item 13) Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of life questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented. | Baseline and up to approximately 5 years |
| Change from Baseline in the EORTC-Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score | The EORTC QLQ-CR29 is a health-related quality-of life questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented. | Baseline and up to approximately 5 years |
| Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in global health status (GHS) (EORTC QLQ-C30 Item 29) & quality of life (QoL) combined score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 5 years |
| TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 5 years |
| TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 5 years |
| TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 5 years |
| TTD in EORTC QLQ-CR29 Bloating (Item 37) Score | The EORTC QLQ-CR29 is a health-related quality-of life questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 5 years |
| University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087) | Recruiting | Fort Collins | Colorado | 80528 | United States |
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| Rocky Mountain Cancer Centers (RMCC) ( Site 8000) | Recruiting | Lone Tree | Colorado | 80124 | United States |
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| Florida Cancer Specialists - South ( Site 7002) | Recruiting | Fort Myers | Florida | 33901 | United States |
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| Orlando Health Cancer Institute ( Site 0065) | Recruiting | Orlando | Florida | 32806 | United States |
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| Florida Cancer Specialists - North ( Site 7001) | Recruiting | St. Petersburg | Florida | 33705 | United States |
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| Florida Cancer Specialists - East ( Site 7000) | Recruiting | West Palm Beach | Florida | 33401 | United States |
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| Saint Alphonsus Regional Medical Center ( Site 0085) | Recruiting | Boise | Idaho | 83706 | United States |
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| Accellacare of Duly ( Site 2015) | Recruiting | Lisle | Illinois | 60532 | United States |
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| University of Iowa ( Site 0074) | Recruiting | Iowa City | Iowa | 52242 | United States |
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| University of Kentucky ( Site 0055) | Recruiting | Lexington | Kentucky | 40536 | United States |
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| Norton Cancer Institute, Audubon Hospital Campus ( Site 0054) | Recruiting | Louisville | Kentucky | 40217 | United States |
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| Greater Baltimore Medical Center ( Site 0068) | Recruiting | Baltimore | Maryland | 21204 | United States |
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| Hattiesburg Clinic ( Site 0064) | Recruiting | Hattiesburg | Mississippi | 39401 | United States |
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| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000) | Recruiting | Billings | Montana | 59102 | United States |
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| University Of Nebraska Medical Center ( Site 0078) | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Renown Regional Medical Center ( Site 0056) | Recruiting | Reno | Nevada | 89502 | United States |
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| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060) | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Atlantic Health System ( Site 0093) | Recruiting | Summit | New Jersey | 07901 | United States |
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| San Juan Oncology Associates, P.C ( Site 2011) | Recruiting | Farmington | New Mexico | 87401 | United States |
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| Ellis Hospital ( Site 0098) | Recruiting | Schenectady | New York | 12308 | United States |
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| Miami Valley Hospital South ( Site 0075) | Recruiting | Centerville | Ohio | 45459 | United States |
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| Texas Oncology - DFW ( Site 8002) | Recruiting | Dallas | Texas | 75246 | United States |
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| UT Southwestern Medical Center ( Site 0059) | Recruiting | Dallas | Texas | 75390 | United States |
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| Texas Oncology - Northeast Texas ( Site 8001) | Recruiting | Denison | Texas | 75020 | United States |
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| Texas Oncology - San Antonio ( Site 8004) | Recruiting | San Antonio | Texas | 78240 | United States |
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| Community Cancer Trials of Utah ( Site 0086) | Recruiting | Ogden | Utah | 84405 | United States |
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| University of Virginia ( Site 0080) | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Virginia Cancer Specialists, PC ( Site 0069) | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Fred Hutchinson Cancer Center ( Site 0076) | Recruiting | Seattle | Washington | 98109 | United States |
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| West Virginia University ( Site 2017) | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0110) | Recruiting | Berazategui | Buenos Aires | B1884BBF | Argentina |
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| Hospital Italiano de Buenos Aires ( Site 0102) | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1199ABB | Argentina |
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| Instituto Alexander Fleming ( Site 0101) | Recruiting | Mar del Plata | Buenos Aires | C1426ANZ | Argentina |
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| Fundacion Estudios Clinicos ( Site 0105) | Recruiting | Rosario | Santa Fe Province | S2000CEJ | Argentina |
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| Sanatorio Parque ( Site 0103) | Recruiting | Rosario | Santa Fe Province | S2000CUB | Argentina |
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| Hospital Privado Universitario de Córdoba ( Site 0108) | Recruiting | Córdoba | X5016KEH | Argentina |
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| Wollongong Hospital ( Site 0453) | Recruiting | Wollongong | New South Wales | 2500 | Australia |
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| Sunshine Coast University Hospital ( Site 0451) | Recruiting | Birtinya | Queensland | 4575 | Australia |
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| Monash Health ( Site 0454) | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Western Health-Sunshine & Footscray Hospitals ( Site 0450) | Recruiting | St Albans | Victoria | 3021 | Australia |
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| Hospital de Câncer de Recife ( Site 0158) | Recruiting | Recife | Pernambuco | 50040-000 | Brazil |
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| Hospital de Caridade de Ijuí ( Site 0150) | Recruiting | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
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| Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153) | Recruiting | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
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| Hospital Nossa Senhora da Conceição ( Site 0156) | Recruiting | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
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| CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157) | Recruiting | Florianópolis | Santa Catarina | 88020-210 | Brazil |
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| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155) | Recruiting | Barretos | São Paulo | 14784-400 | Brazil |
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| Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159) | Recruiting | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
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| COE Ensino e Pesquisa ( Site 0151) | Recruiting | São José dos Campos | São Paulo | 12242-660 | Brazil |
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| Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160) | Recruiting | São Paulo | 01209-000 | Brazil |
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| IBCC - Núcleo de Pesquisa e Ensino ( Site 0154) | Recruiting | São Paulo | 04014-002 | Brazil |
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| Cancercare Manitoba ( Site 0009) | Recruiting | Winnipeg | Manitoba | R3E 0V9 | Canada |
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| Moncton Hospital - Horizon Health Network ( Site 0011) | Recruiting | Moncton | New Brunswick | E1C 6Z8 | Canada |
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| Princess Margaret Cancer Centre ( Site 0001) | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| CIUSSS- saguenay-Lac-Saint-Jean ( Site 0007) | Recruiting | Chicoutimi | Quebec | G7H 5H6 | Canada |
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| Jewish General Hospital ( Site 0006) | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| CIDO SpA ( Site 0212) | Recruiting | Temuco | Araucania | 4810148 | Chile |
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| Clínica Puerto Montt ( Site 0206) | Recruiting | Port Montt | Los Lagos Region | 5500243 | Chile |
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| Oncocentro Valdivia ( Site 0204) | Recruiting | Valdivia | Los Ríos Region | 5112129 | Chile |
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| Fundacion Arturo Lopez Perez ( Site 0201) | Recruiting | Santiago | Region M. de Santiago | 7500921 | Chile |
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| Centro de Oncología de Precisión ( Site 0207) | Recruiting | Santiago | Region M. de Santiago | 7560908 | Chile |
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| Clínica UC San Carlos de Apoquindo ( Site 0211) | Recruiting | Santiago | Region M. de Santiago | 7620002 | Chile |
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| CECIM ( Site 0210) | Recruiting | Santiago | Region M. de Santiago | 8331143 | Chile |
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| Bradfordhill ( Site 0200) | Recruiting | Santiago | Region M. de Santiago | 8420383 | Chile |
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| Clínica RedSalud Vitacura ( Site 0202) | Recruiting | Vitacura | Region M. de Santiago | 7650018 | Chile |
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| ONCOCENTRO APYS ( Site 0203) | Recruiting | Viña del Mar | Valparaiso | 2520598 | Chile |
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| Anhui Provincial Cancer Hospital ( Site 0803) | Recruiting | Hefei | Anhui | 230031 | China |
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| The Second Affiliated Hospital of Anhui Medical University ( Site 0813) | Recruiting | Hefei | Anhui | 230601 | China |
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| Peking Union Medical College Hospital ( Site 0824) | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Peking University First Hospital(Daxing Area) ( Site 0838) | Recruiting | Beijing | Beijing Municipality | 102627 | China |
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| Chongqing University Cancer Hospital ( Site 0808) | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Chongqing University Three Gorges Hospital ( Site 0837) | Recruiting | Wanzhou | Chongqing Municipality | 404199 | China |
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| Fujian Cancer Hospital ( Site 0807) | Recruiting | Fuzhou | Fujian | 350014 | China |
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| The First Affiliated Hospital of Xiamen University ( Site 0806) | Recruiting | Xiamen | Fujian | 361003 | China |
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| Zhongshan Hospital Affiliated to Xiamen University ( Site 1902) | Recruiting | Xiamen | Fujian | 361004 | China |
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| Sun Yat-Sen University Cancer Center ( Site 0800) | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Southern Medical University Nanfang Hospital ( Site 0812) | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828) | Recruiting | Guangzhou | Guangdong | 510655 | China |
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| The University of Hong Kong - Shenzhen Hospital ( Site 1903) | Recruiting | Shenzhen | Guangdong | 518053 | China |
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| Guangxi Medical University Affiliated Tumor Hospital ( Site 0804) | Recruiting | Nanning | Guangxi | 530200 | China |
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| Harbin Medical University Cancer Hospital ( Site 0847) | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Cancer Hospital ( Site 0822) | Recruiting | Zhengzhou | Henan | 450008 | China |
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| Tongji Hospital Tongji Medical,Science & Technology ( Site 0839) | Recruiting | Wuhan | Hubei | 430030 | China |
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| Hubei Cancer Hospital ( Site 0814) | Recruiting | Wuhan | Hubei | 430079 | China |
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| Hunan Cancer Hospital ( Site 0815) | Recruiting | Changsha | Hunan | 410013 | China |
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| The Third Xiangya Hospital of Central South University ( Site 0834) | Recruiting | Changsha | Hunan | 410013 | China |
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| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825) | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| The First Affiliated Hospital of Nanchang University ( Site 0826) | Recruiting | Nanchang | Jiangxi | 330200 | China |
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| The First Affiliated Hospital of Xi an Jiaotong University ( Site 0802) | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| Jinan Central Hospital ( Site 0817) | Recruiting | Jinan | Shandong | 250013 | China |
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| Zhongshan Hospital of Fudan University ( Site 0832) | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Fudan University Shanghai Cancer Center ( Site 0816) | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 1906) | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| First Affiliated Hospital of Shanxi Medical University ( Site 0843) | Recruiting | Taiyuan | Shanxi | 030001 | China |
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| West China Hospital, Sichuan University ( Site 0805) | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Sichuan Cancer hospital. ( Site 0831) | Recruiting | Chengdu | Sichuan | 610213 | China |
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| First Affiliated Hospital of Kunming Medical University ( Site 0845) | Recruiting | Kunming | Yunnan | 650032 | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0801) | Recruiting | Hangzhou | Zhejiang | 310017 | China |
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| Zhejiang Cancer Hospital ( Site 0821) | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| The First Affiliated Hospital of Wenzhou Medical University ( Site 0840) | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| Hospital Universitario San Ignacio ( Site 0254) | Recruiting | Bogota | Cundinamarca | 110231 | Colombia |
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| IMAT S.A.S ( Site 0252) | Recruiting | Montería | Departamento de Córdoba | 230002 | Colombia |
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| Oncologos Del Occidente ( Site 0255) | Recruiting | Pereira | Risaralda Department | 660001 | Colombia |
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| Tampere University Hospital ( Site 1001) | Recruiting | Tampere | Pirkanmaa | 33520 | Finland |
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| Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000) | Recruiting | Helsinki | Uusimaa | 00290 | Finland |
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| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058) | Recruiting | Nice | Alpes-Maritimes | 06202 | France |
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| Centre François Baclesse ( Site 1061) | Recruiting | Caen | Calvados | 14000 | France |
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| CHU Rangueil ( Site 1063) | Recruiting | Toulouse | Haute-Garonne | 31059 | France |
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| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064) | Recruiting | Limoges | Limousin | 87042 | France |
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| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053) | Recruiting | Vandœuvre-lès-Nancy | Lorraine | 54511 | France |
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| Institut Jean Godinot ( Site 1054) | Recruiting | Reims | Marne | 51100 | France |
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| Institut de Cancérologie de l'Ouest ( Site 1062) | Recruiting | Angers | Pays de la Loire Region | 49055 | France |
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| CHU Charles Nicolle ( Site 1066) | Recruiting | Rouen | Seine-Maritime | 76031 | France |
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| Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065) | Recruiting | Avignon | Vaucluse | 84918 | France |
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| Hôpital Saint Antoine ( Site 1051) | Recruiting | Paris | 75571 | France |
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| Hôpital Européen Georges Pompidou ( Site 1050) | Recruiting | Paris | Île-de-France Region | 75015 | France |
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| Katholisches Marienkrankenhaus gGmbH ( Site 1103) | Recruiting | Hamburg | 22087 | Germany |
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| Asklepios Klinik Altona ( Site 1100) | Recruiting | Hamburg | 22763 | Germany |
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| Prince of Wales Hospital. ( Site 0500) | Recruiting | Hong Kong | Hong Kong |
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| Queen Mary Hospital ( Site 0501) | Recruiting | Hong Kong | Hong Kong |
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| Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1204) | Recruiting | Pécs | Baranya | 7624 | Hungary |
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| Rambam Health Care Campus ( Site 1253) | Recruiting | Haifa | 3109601 | Israel |
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| Hadassah Medical Center ( Site 1252) | Recruiting | Jerusalem | 9112001 | Israel |
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| Rabin Medical Center ( Site 1251) | Recruiting | Petah Tikva | 4941492 | Israel |
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| Sheba Medical Center ( Site 1254) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Sourasky Medical Center ( Site 1255) | Recruiting | Tel Aviv | 6423906 | Israel |
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| AOU Cagliari ( Site 1306) | Recruiting | Monserrato | Cagliari | 09042 | Italy |
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| ASST Grande Ospedale Metropolitano Niguarda ( Site 1300) | Recruiting | Milan | Lombardy | 20162 | Italy |
|
| Ospedale San Raffaele. ( Site 1305) | Recruiting | Milan | 20132 | Italy |
|
| Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1302) | Recruiting | Naples | 80131 | Italy |
|
| Istituto Oncologico Veneto IRCCS ( Site 1307) | Recruiting | Padova | 35128 | Italy |
|
| Azienda USL della Romagna ( Site 1303) | Recruiting | Ravenna | 48100 | Italy |
|
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304) | Recruiting | Verona | 37134 | Italy |
|
| National Cancer Center Hospital East ( Site 0851) | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
|
| Teine Keijinkai Hospital ( Site 0864) | Recruiting | Sapporo | Hokkaido | 006-8555 | Japan |
|
| Kagawa University Hospital ( Site 0861) | Recruiting | Kita-gun | Kagawa-ken | 761-0793 | Japan |
|
| Tohoku University Hospital ( Site 0853) | Recruiting | Sendai | Miyagi | 980-8574 | Japan |
|
| Kindai University Hospital ( Site 0854) | Recruiting | Sakai | Osaka | 590-0197 | Japan |
|
| Saitama Medical University International Medical Center ( Site 0860) | Recruiting | Hidaka | Saitama | 350-1298 | Japan |
|
| Saitama Prefectural Cancer Center ( Site 0857) | Recruiting | Kitaadachi-gun | Saitama | 362-0806 | Japan |
|
| Shizuoka Cancer Center ( Site 0856) | Recruiting | Sunto-gun | Shizuoka | 411-8777 | Japan |
|
| Nippon Medical School Hospital ( Site 0859) | Recruiting | Bunkyo | Tokyo | 113-8603 | Japan |
|
| National Cancer Center Hospital ( Site 0850) | Recruiting | Chūō | Tokyo | 104-0045 | Japan |
|
| Cancer Institute Hospital of JFCR ( Site 0863) | Recruiting | Koto | Tokyo | 135-8550 | Japan |
|
| Chiba Cancer Center ( Site 0858) | Recruiting | Chiba | 260-8717 | Japan |
|
| Kyushu University Hospital ( Site 0862) | Recruiting | Fukuoka | 812-8582 | Japan |
|
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0852) | Recruiting | Osaka | 541-8567 | Japan |
|
| Hospital Pulau Pinang ( Site 0550) | Recruiting | George Town | Pulau Pinang | 10990 | Malaysia |
|
| National Cancer Institute ( Site 0552) | Recruiting | Putrajaya | Putrajaya | 62250 | Malaysia |
|
| Sarawak General Hospital ( Site 0551) | Recruiting | Kuching | Sarawak | 93586 | Malaysia |
|
| Oncare Oncology (Servicios de Oncologia Médica Integral S.A. de C.V. - unidad San Pedro) ( Site 0407) | Recruiting | San Pedro Garza García | Nuevo León | 66220 | Mexico |
|
| Centro de Investigación Oncológica Galerías SC ( Site 0408) | Recruiting | Aguascalientes | 20124 | Mexico |
|
| Centro de Investigacion Clinica de Oaxaca ( Site 0402) | Recruiting | Oaxaca City | 68020 | Mexico |
|
| Radboudumc ( Site 1354) | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
|
| Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352) | Recruiting | Breda | North Brabant | 4818 CK | Netherlands |
|
| Amsterdam UMC, locatie VUmc ( Site 1351) | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
|
| Erasmus Medisch Centrum ( Site 1353) | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
|
| Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457) | Recruiting | Poznan | Greater Poland Voivodeship | 61-866 | Poland |
|
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1451) | Recruiting | Warsaw | Masovian Voivodeship | 02-034 | Poland |
|
| Mrukmed ( Site 1450) | Recruiting | Rzeszów | Podkarpackie Voivodeship | 35-021 | Poland |
|
| Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1452) | Recruiting | Gliwice | Silesian Voivodeship | 44-101 | Poland |
|
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 1456) | Recruiting | Koszalin | West Pomeranian Voivodeship | 75-581 | Poland |
|
| Institutul Oncologic Cluj ( Site 1502) | Recruiting | Cluj-Napoca | Cluj | 400015 | Romania |
|
| SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501) | Recruiting | Cluj-Napoca | Cluj | 407280 | Romania |
|
| Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500) | Recruiting | Craiova | Dolj | 200746 | Romania |
|
| Fundeni Clinical Institute-Medical Oncology ( Site 1504) | Recruiting | Bucharest | 022328 | Romania |
|
| Institutul Regional de Oncologie ( Site 1505) | Recruiting | Iași | 700483 | Romania |
|
| National Cancer Centre Singapore ( Site 0650) | Recruiting | Singapore | Central Singapore | 168583 | Singapore |
|
| National Cancer Center ( Site 0702) | Recruiting | Goyang-si | Kyonggi-do | 10408 | South Korea |
|
| Seoul National University Bundang Hospital ( Site 0705) | Recruiting | Seongnam-si | Kyonggi-do | 13620 | South Korea |
|
| The Catholic University of Korea St. Vincent s Hospital ( Site 0703) | Recruiting | Suwon | Kyonggi-do | 16247 | South Korea |
|
| Samsung Medical Center ( Site 0708) | Recruiting | Gangnam | Seoul | 06351 | South Korea |
|
| Asan Medical Center ( Site 0707) | Recruiting | Songpa-gu | Seoul | 05505 | South Korea |
|
| Kyungpook National University Chilgok Hospital ( Site 0701) | Recruiting | Buk-Gu | Taegu-Kwangyokshi | 41404 | South Korea |
|
| Seoul National University Hospital ( Site 0706) | Recruiting | Seoul | 03080 | South Korea |
|
| Korea University Guro Hospital ( Site 0704) | Recruiting | Seoul | 08308 | South Korea |
|
| Institut Català d'Oncologia (ICO) - Badalona ( Site 1552) | Recruiting | Badalona | Barcelona | 08916 | Spain |
|
| Hospital Universitario Marqués de Valdecilla ( Site 1551) | Recruiting | Santander | Cantabria | 39008 | Spain |
|
| Hospital Insular de Gran Canaria ( Site 1558) | Recruiting | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
|
| Hospital Universitario Central de Asturias ( Site 1550) | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
|
| Hospital Universitari Vall d'Hebron ( Site 1553) | Recruiting | Barcelona | 08035 | Spain |
|
| HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554) | Recruiting | Madrid | 28007 | Spain |
|
| Hospital Clinico San Carlos ( Site 1555) | Recruiting | Madrid | 28040 | Spain |
|
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556) | Recruiting | Seville | 41013 | Spain |
|
| Instituto Valenciano de Oncologia - IVO ( Site 1557) | Recruiting | Valencia | 46009 | Spain |
|
| National Cheng Kung University Hospital ( Site 0754) | Recruiting | Tainan | 704 | Taiwan |
|
| National Taiwan University Hospital ( Site 0751) | Recruiting | Taipei | 100 | Taiwan |
|
| Taipei Veterans General Hospital ( Site 0752) | Recruiting | Taipei | 112 | Taiwan |
|
| Chang Gung Memorial Hospital - Linkou Branch ( Site 0753) | Recruiting | Taoyuan | 333 | Taiwan |
|
| Hacettepe Universite Hastaneleri ( Site 1650) | Recruiting | Sıhhiye | Ankara | 06230 | Turkey (Türkiye) |
|
| Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1652) | Recruiting | Adana | 01250 | Turkey (Türkiye) |
|
| Gazi Universitesi ( Site 1651) | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
|
| Dicle Üniversitesi ( Site 1654) | Recruiting | Diyarbakır | 21200 | Turkey (Türkiye) |
|
| Istanbul Universitesi Cerrahpasa ( Site 1656) | Recruiting | Istanbul | 34098 | Turkey (Türkiye) |
|
| Ege Universitesi Hastanesi ( Site 1653) | Recruiting | Izmir | 35080 | Turkey (Türkiye) |
|
| MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706) | Recruiting | Cherkasy | Cherkasy Oblast | 18009 | Ukraine |
|
| RMNE "Bukovyna Clinical Oncology Center" ( Site 1709) | Recruiting | Chernivtsi | Chernivetska Oblast | 58013 | Ukraine |
|
| MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701) | Recruiting | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
|
| CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702) | Recruiting | Kropyvnytskyi | Kirovohrad Oblast | 25011 | Ukraine |
|
| MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708) | Recruiting | Lviv | Lviv Oblast | 79059 | Ukraine |
|
| MNE "Central City Hospital" ( Site 1711) | Recruiting | Rivne | Rivne Oblast | 33017 | Ukraine |
|
| ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712) | Recruiting | Lutsk | Volyn Oblast | 43018 | Ukraine |
|
| Uzhgorod Central City Clinical Hospital ( Site 1700) | Recruiting | Uzhhorod | Zakarpattia Oblast | 88000 | Ukraine |
|
| Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704) | Recruiting | Kyiv | 03057 | Ukraine |
|
| SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713) | Recruiting | Kyiv | 03126 | Ukraine |
|
| LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703) | Recruiting | Kyiv | 03151 | Ukraine |
|
| Heartlands Hospital ( Site 1759) | Recruiting | Birmingham | England | B9 5ss | United Kingdom |
|
| University College London Hospitals ( Site 1750) | Recruiting | London | London, City of | NW1 2PG | United Kingdom |
|
| Churchill Hospital ( Site 1756) | Recruiting | Oxford | Oxfordshire | ox3 7le | United Kingdom |
|
| University Hospital Coventry & Warwickshire ( Site 1761) | Recruiting | Coventry | Warwickshire | CV2 2DX | United Kingdom |
|
| The Christie NHS Foundation Trust ( Site 1755) | Recruiting | Manchester | M20 4BX | United Kingdom |
|
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000068818 | Cetuximab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided