Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01276379
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2011-01-12
Brief Title:
Study Evaluating Biomarkers in Patients With Colorectal Cancer and Native KRAS Treated With Chemotherapy Cetuximab
Sponsor:
Grupo Espanol Multidisciplinario del Cancer Digestivo
Organization:
Grupo Espanol Multidisciplinario del Cancer Digestivo
Study Overview
Official Title:
Single-Arm Multicenter Prospective Phase 2 Study for the Evaluation of Biomarkers in Patients With Advanced or Metastatic Colorectal Cancer With Wild Type KRAS Treated Biweekly With Chemotherapy and Cetuximab as First-Line Treatment
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSIBA
Brief Summary:
Advanced colorectal cancer ACRC is a heterogeneous disease and classification of patients is nowadays inefficient Roughly twenty per cent of patients present with favorable figures less than 4 liver nodules and less than 5 cm and are suitable for local treatments surgery or local-ablative therapies Additionally 10-15 of patients have poor performance status PS 2 or are severe disabled due to geriatric syndromes orand co-morbid diseases that preclude any treatment strategies than best supportive care alone The rest of patients fit patients not suitable for radical treatments constitute the population of patients treated with palliative therapies Despite of it not all these patients have the same prognosis Patients with PS 01 and levels of LDH ULN Intermediate-risk patients have better PFS and OS irrespective of therapy in all randomized clinical trials de Gramont et al JCO 2000 Douillard et al Lancet 2000 Koopman et al 2007
CRYSTAL trial shows a benefit in PFS 15 months in RASWT of FOLFIRI plus cetuximab compared with FOLFIRI alone Nowadays the selection of patients for cetuximab treatment is based on mutational status of KRAS which allow to select those patients who will not respond to therapy Other surrogate markers of activity should be also evaluated Our hypothesis is that the suggested biomarkers will allow the selection of the patients who will benefit the most from the biweekly cetuximab treatment
CRYSTAL trial shows a benefit in PFS 15 months in RASWT of FOLFIRI plus cetuximab compared with FOLFIRI alone Nowadays the selection of patients for cetuximab treatment is based on mutational status of KRAS which allow to select those patients who will not respond to therapy Other surrogate markers of activity should be also evaluated Our hypothesis is that the suggested biomarkers will allow the selection of the patients who will benefit the most from the biweekly cetuximab treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-019236-12 | EUDRACT_NUMBER | None | None |