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Observational Study on Treatment of Metastatic Colorectal Cancer and the Role of K-Ras (CALLAS)

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01651013
First received: July 24, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.


Condition Phase
Metastatic Colorectal Cancer
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentered Observational Prospective Cohort Study on the Treatment of Metastatic Colorectal Cancer and the Role of Evaluating K-Ras

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • percentage of patients enrolled in a clinical trial [ Time Frame: two years ] [ Designated as safety issue: No ]
  • percentage of patients who undergo K-Ras mutation study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Percentage of patients with K-Ras mutation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • metastatic colorectal cancer treatments used in clinical practice, according to participating center [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • patient outcome according to K-Ras status [ Time Frame: two years ] [ Designated as safety issue: No ]
  • estimated costs per treatment per center [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • disease outcome per patient per treatment received [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • factors that influence patient prognosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    exploratory analyses

  • predictive factors for response to treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    exploratory analyses


Estimated Enrollment: 500
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
metastatic colorectal cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients at participating Institutes who are candidate for first-line treatment of metastatic colorectal cancer

Criteria

Inclusion Criteria:

  • Histologic diagnosis colorectal carcinoma
  • Metastatic disease
  • Signed informed consent

Exclusion Criteria:

  • Prior treatment of metastatic colorectal cancer
  • Refusal or incapability of providing informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651013

Contacts
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Marilina Piccirillo, M.D. +39 081 5903383 marilina.piccirillo@usc-intnapoli.net

Locations
Italy
A.O.G. Rummo Recruiting
Benevento, Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico Recruiting
Napoli, Italy
Ospedale Civile Umberto I Recruiting
Nocera Inferiore, Italy
C:R.O. Regione Basilicata Ospedale Giustino Fortunato Recruiting
Rionero in Vulture, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: R. V. Iaffaioli, M.D. National Cancer Institute, Naples
Principal Investigator: G. Nasti, M.D. National Cancer Institute, Naples
Principal Investigator: M. C. Piccirillo, M.D. National Cancer Institute, Naples
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01651013     History of Changes
Other Study ID Numbers: CALLAS
Study First Received: July 24, 2012
Last Updated: February 27, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013