Correlation Between RECIST, Morphologic Response by CT- Histopathologic Response in Hepatic Metastasis Secondary to Colorectal Cancer

NCT01493713 | Completed Phase 4

• 1 other identifier: GEMCAD-10-06
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Colorectal Cancer; Hepatic Metastasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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.

  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

Study Arms (1)

Bevacizumab, XELOX

EXPERIMENTAL

Bevacizumab in combination with XELOX

Other: Evaluate the correlation of overall different objective response.

Interventions

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)

Bevacizumab, XELOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≤ 4 metastases
• Size \< 10 cm
• Technically feasible R0 resection, with a residual liver volume of no less than 30%
• 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:
• Hemoglobin ≥ 9.0 g/dl (a transfusion can be given before treatment).
• Platelet count ≥ 100 × 109/L.

You may not qualify if:

• Patients with non-resectable hepatic metastases at the time of enrollment.
• Previous systemic or local treatment of metastatic disease.
• Presence of metastatic extrahepatic disease.
• Neo-adjuvant or adjuvant chemotherapy/radiotherapy in the 6 months prior to entering the study.
• Use of any investigational drug in the 4 weeks before starting the study treatment.
• Current or recent (in the 10 days prior to the first administration of the study treatment) use of acetylsalicylic acid (\> 325 mg/day) or clopidogrel (75 mg/day).
• Current presence of peripheral neuropathy = 1 (CTCAE).
• Hypertension not properly controlled (defined as systolic pressure \> 150 mm Hg and/or diastolic pressure \> 100 mm Hg in repeated measurements), despite optimal medical management.
• Previous history of hypertensive episodes or hypertensive encephalopathy.
• CHF class II or higher of the NYHA classification.
• History of myocardial infarction or unstable angina within the 6 months prior to starting the study treatment.
• Significant vascular disease (e.g., aortic aneurysm requiring surgery, pulmonary embolism or recent peripheral arterial thrombosis) in the 6 months prior to the start of the study treatment.
• History of hemoptysis (equivalent to = ½ teaspoon of red-colored blood per episode) in the month prior to the study treatment.
• Major surgery, open surgical biopsy or significant trauma in the 4 weeks prior to the start of study treatment. Thick-needle biopsy of a major organ in the 7 days prior to entering the study. Insertion of a vascular access \> 3 days before entering the study is allowed.
• Tests or history of significant hemorrhagic diathesis or coagulation disorder (in the absence of anticoagulation).

Sponsors & Collaborators

• Grupo Espanol Multidisciplinario del Cancer Digestivo: lead

Study Sites (21)

Hospital de Donostia

San Sebastián, Guipúzcoa, 20014, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Mallorca, 07198, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clìnic

Barcelona, 08036, Spain

Location

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Complejo Hospitalario Xeral Calde

Lugo, 27004, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Complejo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

Location

Hospital de Sabadell

Sabadell, 08208, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Arnau de Vilanova de Valencia

Valencia, 46015, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, 36036, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ruth Vera, Dr

  Hospital de Navarra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 16, 2011
• Study Start: November 16, 2011
• Primary Completion: December 8, 2014
• Study Completion: December 18, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (21)