A Multicenter, Double Blind, Placebo controlled, Randomized study of TroVax vs Placebo in the First Line treatment of Patients with Metastatic Colorectal Cancer receiving Standard of Care.-----------------------------------------------------------------------------------------------Estudio multicéntrico, doble ciego, controlado con placebo y aleatorizado de TroVax? frente a placebo en el tratamiento de primera línea de pacientes con cáncer colorrectal metastásico que reciben el tratamiento habitual. - FLAMENCO

• Conditions: Metastatic Colorectal Adenocarcinoma.-----------------------------------------------Adenocarcinoma Colorectal Metastásico.; MedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

• Registration Number: EUCTR2007-005639-26-ES
• Lead Sponsor: Oxford BioMedica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-05
• Last Update Posted: 10 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

- Patients with histology/cytology confirmed colorectal adenocarcinoma
- Metastatic colorectal cancer
- No prior palliative chemotherapy
- Patient's informed consent obtained, signed and dated.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Related to study methodology
- Age < 18 years old
- ECOG performance status > 2
- (Neo)Adjuvant chemotherapy if <6 months between end of chemotherapy and relapse.
- Prior Radiotherapy (< 6 weeks) or surgery (< 3 weeks) before randomization
- Patients with resectable liver or lung metastasis
- Known brain metastasis or leptomeningeal disease
- History of other neoplasms
- Life expectancy < 3 months
- Any contraindication to administer the chosen SOC

* Exclusion criteria related to Standard of Care

* Exclusion criteria related to TroVax
- Lymphocytes < 1 x 10e9/L
- Serious infection within 28 days prior to randomization
- History of hypersensitivity to vaccinia vaccination, egg protein or neomycin
- Known positive test to HIV or active and/or requiring treatment hepatitis B or C
- Active eczema with lesions on the skin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To compare overall survival (OS) with TroVax vs. Placebo in patients with metastatic colorectal cancer receiving standard of care (SOC) in first line treatment.;Secondary Objective: - To compare PFS between TroVax and Placebo arms.<br> - To compare Objective Response rate (ORR) between TroVax and Placebo arms.<br> - To assess the safety and tolerability of TroVax and Placebo arms.;Primary end point(s): - Overall survival defined as the time interval from the date of randomization to the date of death due to any cause. <br>In absence of confirmation of death, survival time will be censored at the earlier of the last date the patient is known to be alive and the study cut-off date.