Clinical Trial 21216

• Overview

  Study Title:

  Prospective Study of the Value of CRASH and CARG Toxicity Scores in Predicting Targeted Therapy Toxicity in Geriatric Oncology

  Summary:

  The objective of this study is to evaluate the Chemotherapy Risk Assessment Scale for High‑Age Patients (CRASH) and Cancer Aging Research Group (CARG) tools for their predictive ability for grade 3-5 toxicities in a cohort of older adults with cancer treated with targeted therapy.

  Objective:

  The Primary Objectives: 1. Evaluation the CRASH and CARG tools for its predictive ability for grade 3 to 5 toxicity in a cohort of older adults with cancer being treated with targeted therapy. 2. Occurrence of severe toxicity, defined as grade 4 hematological and/or grade 3-4 nonhematological toxicity. 3. Assessed the predictive capability of this model for targeted therapy toxicity in comparison to KPS/ECOG Performance Status, a commonly used oncology performance status measure. The Secondary Objectives: 1. Feasibility of applying the CRASH and CARG tools. 2. Rate of unplanned hospitalizations. 3. Rate of dose reductions. 4. Rate of dose delays. 5. Rate of early treatment discontinuation. 6. Time to first severe toxicity, defined from day one of treatment to first day of documentation of qualifying grade of toxicity. 7. Evaluation of the Correlation between the CARG score, CRASH score and physicians' reported of targeted toxicity. 8. Assessment of targeted therapy response in elderly.

• Inclusion Criteria

  Inclusion Criteria
  • Patients ≥65 years old.
  • Cancer confirmed histologically of the following types: solid tumor or hematologic malignancy other than leukemia. Any stage will be accepted.
  • Intended to start a new targeted therapy. The regimen must be a published regimen. This can be a first line treatment, adjuvant included, or treatment after up to three previous line of therapies. If the patient has been pretreated, a minimum of 4 weeks must have elapsed since the previous therapy including chemotherapy, targeted and immunotherapy
  • English speaking.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Patient treated in a context of clinical trial.
  • Patient with altered mental status or psychiatric disorder that, in the opinion of investigator, would preclude a valid patient consent.
  • Inability to complete the questionnaires (insufficient understanding of the questions. Help for physical impairments is accepted).
  • Expected survival > Planned concomitant therapy targeted-chemo, targeted-immunotherapy, targeted radiation therapy. For any other form of radiation therapy, the minimum interval must be 4 weeks from completion.
  • Other exclusions may apply

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