FRESH-PEF2887-en
Evaluation of targeted therapies in patients receiving first-line treatment for metastatic colorectal cancer: cetuximab in the real-life conditions of use
EREBUS
| Name | Country code |
|---|---|
| France | fr |
['Clinical data']
Individuals
| Topic | Vocabulary |
|---|---|
| Oncology | health theme |
| Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic, central nervous system or related tissues | cim-11 |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"Patient with metastatic colorectal cancer initiating first-line treatment with cetuximab® between 1 January 2009 and 31 December 2010, whether or not treatment is continued; Patient not previously treated by cetuximab®, including during a clinical trial or Temporary Authorisation for Use; Patient naive to palliative metastatic chemotherapyd; No neoadjuvant chemotherapy / adjuvant of primary cancer or interval between the latter and the initiation of first-line treatment with cetuximab® ≥6 months (with a tolerance of 15 days); No neoadjuvant / adjuvant of chemotherapy for metastatic cancer between or interval between the latter and initiation of first-line treatment with cetuximab® ≥12 months (with a tolerance of 1 month ); Patient with unresectable metastases immediately before initiation of cetuximab®; Patient with non-mutated K-RAS; Patient not participating in a clinical trial or treatment conditions considered to be unaffected by the coordinating center; Patient without locoregional relapse; Patient not objecting to data collection.","clusion_E":""}
| Name |
|---|
| Nicholas;MOORE |
| Magali;ROUYER |
| Name | Role |
|---|---|
| UNIVERSITE DE BORDEAUX | sponsor |
| Name |
|---|
| MERCK SANTE |
| Agency name |
|---|
| CNIL |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2010-01-01 | 2012-01-01 |
Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the pharmaceutical company.
{"value":"To be defined","extLink":[]}
| Name | |
|---|---|
| Annie;FOURRIER-REGLAT | annie.fourrier-reglat@u-bordeaux.fr |
| Nicholas;MOORE | nicholas.moore@u-bordeaux.fr |