Brief Title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)

INTRODUCTION

• Org Study ID: IB 2015-08
• Secondary ID: ID-RCB number 2015-A01417-42
• NTC ID: NCT02704832
• Sponsor: Institut Bergonié

BRIEF SUMMARY

Randomized trials have already demonstrated that geriatric intervention was able to improve
survival in the general elderly population but only a few have been performed in cancer
patients. At the end, these data are not sufficient to consider geriatric intervention as
validated in this setting. Case Management, coordinated by a geriatrician and a trained
nurse, could improve prognosis of elderly patients with cancer. This approach, can be
integrated in daily oncology practice. This strategy will be compared to usual oncological
management in a randomized phase III trial.

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DETAILED DESCRIPTION

Patients will first be screened using the G8 screening tool. If the resulting score is
altered (G8 <= 14), patients will be included in the main study and randomized according to 2
modalities: Arm A / Usual care (treatment according to on-going regimens in oncology) or Arm
B /Case management (assessment of the patient by the nurse and the geriatrician with
interventions as prescribed by the geriatrician). The intervention will be considered
effective if, at one year, compared to usual care there is a significant clinical improvement
in overall survival (OS) without a significant deterioration or/and clinical improvement of
at least one of the targeted quality of life (QoL) scores, without significant clinical
deterioration in at least one of the targeted QoL scores and without significant difference
in OS in favor of usual care.

If the resulting score is normal (G8 > 14), patients will be treated according to their
physician-in-charge opinion. A minimal set of data will be collected (age, sex, tumor type,
disease stage, performance status (PS), creatinine clearance, albumin and C-Reactive Protein
(CRP) levels mainly) to allow for the characterization of the population in order to compare
our results to those of other published series.

• Overall Status
  Recruiting
• Start Date
  
• Phase
  Phase 3
• Study Type
  Interventional