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Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer (COG-ANGIO)

This study has been terminated.
(lack of recruitment)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01336231
First received: April 12, 2011
Last updated: October 5, 2012
Last verified: April 2011
History of Changes
  Purpose

Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer


Condition
Metastatic Kidney Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • Impact of fatigue, memory problems and attentional [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: No ]
    Assessing the impact of fatigue, memory problems and attentional induced by an anti-angiogenic and study their evolution over time in patients with metastatic kidney cancer.


Secondary Outcome Measures:
  • Parameters of quality of life [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: No ]
    Studying the different parameters of quality of life and their evolution over time.

  • disorders of cognitive functions [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: No ]
    Studying the correlations between disorders of cognitive functions and parameters of quality of life and fatigue.

  • biological disturbances [ Time Frame: up to 9 months after treatment ] [ Designated as safety issue: No ]
    Search for biological disturbances may be related to fatigue and cognitive disorders.

  • Impact of anxiety and depression [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: No ]
    Assessing the impact of anxiety and depression at the waning of treatment

  • List of symptoms [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: No ]
    Compare the list of symptoms considered important by the patient compared to those recorded in the medical record.

  • Impact on the sexuality [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: No ]
    sess the impact on the sexuality of patients with the waning of treatment

  • Effects of different antiangiogenic agents [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: No ]
    Compare the impact on quality of life and cognition side effects of different antiangiogenic agents used


Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients group
Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic

  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 with a metastatic kidney cancer and must beginning a treatment by antiangiogenic

Criteria

Inclusion Criteria:

  • Patient (e) Age (e) over 18 years
  • Kidney cancer metastatic or locally advanced
  • Anti-angiogenic or targeted therapy (bevacizumab, sorafenib, sunitinib, temsirolimus, another molecule or developing or having obtained authorization in this indication) may be associated with interferon or combined together
  • Proposed treatment in first line or second line
  • Brain imaging not finding brain metastases
  • Having signed the informed consent of study participation
  • The patient may have received prior anti-angiogenic

Exclusion Criteria:

  • Cancer of the kidney other than primitive
  • Previous history of cancer other than kidney cancer in complete remission for less than 5 years
  • Patients under 18 years
  • Patients whose treatment is associated with chemotherapy
  • disorders of cognitive functions to existing treatment delivery
  • Pathology psychiatric evolutionary
  • Refusal of participation
  • Patient unable to respond to cognitive tests
  • Drug use
  • Heavy drinking (WHO criteria)
  • History of stroke
  • History of head trauma
  • Brain metastases known
  • MMS below normal compared to existing standards for age and socio-cultural
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336231

Locations
France
Centre François BACLESSE
Caen, Calvados, France, 14076
Hôpital Georges Pompidou
Paris, Ile de France, France, 75908
Centre Henri Becquerel
Rouen, Seine Maritime, France, 76000
CHU
Rouen, Seine Maritime, France, 76038
CHU
Strasbourg, France, 67091
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Francois Baclesse
Hoffmann-La Roche
Investigators
Principal Investigator: Florence JOLY-LOBBEDEZ, PD Centre François Baclesse
  More Information

No publications provided

Responsible Party: Pr Florence JOLY-LOBBEDEZ, Centre François BACLESSE
ClinicalTrials.gov Identifier: NCT01336231     History of Changes
Other Study ID Numbers: COG-ANGIO
Study First Received: April 12, 2011
Last Updated: October 5, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Francois Baclesse:
quality of life
cognitive functions
antiangiogenic agents
kidney cancer
metastatic

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Kidney Diseases
Urologic Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013