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The purpose of this study is to to evaluate the correlation of overall objective response according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic response by CT, and histopathologic response in patients with resectable hepatic metastasis secondary to colorectal cancer treated with bevacizumab in combination with XELOX.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab, XELOX | Experimental | Bevacizumab in combination with XELOX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluate the correlation of overall different objective response. | Other | Evaluate the correlation of overall different objectives response. Chemotherapeutic agents: XELOX scheme (Xeloda; Oxaliplatin) Device: MDCT (MultiDetector Computed Tomography) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of overall objective responses evaluated by conventional imaging techniques with the morphologic response evaluated by MDCT and the histopathologic response after the resection of hepatic metastases. | 2016 |
| Measure | Description | Time Frame |
|---|---|---|
| R0/R1/R2 resectability rate. | 2016 | |
| Progression-free survival (PFS), only in patients who do not undergo metastasis resection. | 2016 | |
| Recurrence-free survival (RFS) in patients who undergo metastasis resection. |
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Inclusion Criteria:
Written informed consent.
Age ≥ 18 years.
ECOG 0-1.
Life expectancy of at least 12 weeks.
Histologic confirmation of adenocarcinoma of the colon or rectum, according to the 7th edition of the TNM classification, with evidence of liver metastases according to RECIST v 1.1 criteria (Annex V). Patients with the diagnosis of liver metastasis presenting synchronically or after a disease-free interval. The primary tumor shall have been resected previously although the inverse approach may be acceptable if the tumor is not very symptomatic. Patients in whom combined surgery of the primary tumor and metastases is planned are not eligible.
Availability of a tumor sample for KRAS gene determination.
No prior chemotherapy treatment for metastatic CRC.
Patients with resectable hepatic metastases of colorectal carcinoma who satisfy the following criteria:
NOTE: Patients with bilateral metastases may be enrolled if they satisfy the above criteria (<4 metastases and size <10 cm).
Adequate bone marrow, liver and kidney function, defined as:
Women of childbearing potential must have a negative pregnancy test in serum or urine in the 7-day period before entering the study. Postmenopausal women must have been amenorrheic during at least 12 months. Likewise, both the men and the women who participate in this study must use effective contraceptive methods (e.g., abstinence, intrauterine device, oral contraceptives, a double barrier method or surgical sterility), beginning upon signing the informed consent form and for at least 6 months after the end of treatment or the last dose, whichever occurs first.
The subject must have the capacity, in the opinion of the investigator, to comply with all the procedures and examinations of study follow-up.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Vera, Dr | Hospital de Navarra | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Donostia | San Sebastián | Guipúzcoa | 20014 | Spain | ||
| Hospital Universitario Fundación Alcorcón |
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| 2016 |
| Safety and toxicity (surgical and therapeutic) of the therapy graded according to CTC v.4.0 | 2016 |
| Overall survival (OS) at 2 and 3 years. | 2016 |
| Examine the influence of a potential predictive and prognostic tumour biomarker -mutations in K-RAS- after start of therapy on overall objective response | 2016 |
| Examine the influence of a potential predictive and prognostic tumour biomarker -mutations in K-RAS- after start of therapy on surgical resection rate | 2016 |
| Examine the influence of a potential predictive and prognostic tumour biomarker -mutations in K-RAS- after start of therapy on survival | 2016 |
| Examine the influence of a potential predictive and prognostic tumour biomarker -mutations in K-RAS- after start of therapy on progression free survival | 2016 |
| Alcorcón |
| Madrid |
| 28922 |
| Spain |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Mallorca | 07198 | Spain |
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Clìnic | Barcelona | 08036 | Spain |
| Hospital Universitario Arnau de Vilanova de Lleida | Lleida | 25198 | Spain |
| Complejo Hospitalario Xeral Calde | Lugo | 27004 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28009 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Complejo Hospitalario Universitario de Ourense | Ourense | 32005 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33006 | Spain |
| Hospital de Sabadell | Sabadell | 08208 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Arnau de Vilanova de Valencia | Valencia | 46015 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | 36036 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| 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 |
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