Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified August 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01026467
First received: December 3, 2009
Last updated: November 20, 2013
Last verified: August 2013

December 3, 2009
November 20, 2013
January 2010
June 2014   (final data collection date for primary outcome measure)
Use of the Frailty Index and/or the geriatric assessment in prediction of toxicity [ Time Frame: Prior to chemotherapy ] [ Designated as safety issue: Yes ]
To determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01026467 on ClinicalTrials.gov Archive Site
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Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
A Phase II Study of Fraility Index and Geriatric Assessment as Predictors of Toxicity to Front-Line Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer

This phase II trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small cell lung cancer. A frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen

PRIMARY OBJECTIVE:

I. To determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy.

OUTLINE:

Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin intravenously (IV) and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients with Stage IV Non-Small Cell Lung Cancer

  • Recurrent Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
  • Drug: carboplatin
    Given IV
    Other Names:
    • Carboplat
    • CBDCA
    • JM-8
    • Paraplat
    • Paraplatin
  • Other: questionnaire administration
Supportive Care (frailty index, geriatric assessment, chemo)
Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses
Interventions:
  • Drug: cisplatin
  • Drug: carboplatin
  • Other: questionnaire administration
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Pathological documentation of non-small cell lung cancer Stage IV disease Prior adjuvant chemotherapy for the earlier stages of non-small cell lung cancer is allowed Patients with brain metastases are allowed on protocol only if they have received brain irradiation and are neurologically stable Patients with other malignancies are allowed on protocol unless they are receiving active treatment (surgery, radiation, chemotherapy or immunotherapy) for the other malignancy Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Prior palliative chemotherapy Pregnant and/or lactating women Prior radiation therapy other than brain irradiation for brain metastases

Both
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No
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United States
 
NCT01026467
CCCWFU 98709, NCI-2009-01451
Yes
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Heidi Klepin Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP