Challenges of conducting a prospective clinical trial for older patients: Lessons learned from NCCTG N0949 (alliance).

ABSTRACT:

Objectives

While the risk of developing colorectal cancer increases with age, there are limited prospective data regarding best treatment in the older adult population. We launched a phase III trial to evaluate difference in treatment outcome for older adults (aged ≥70years) with advanced colorectal cancer. Here we review the challenges faced and reasons for poor accrual to N0949.

Materials and methods

We describe the conceptualization, development and limited results of N0949, a randomized phase III study of fluoropyrimidine/bevacizumab with or without oxaliplatin (mFOLFOX7 or XELOX) as first line chemotherapy for metastatic colorectal cancer. Fluoropyrimidine was physician choice (e.g., 5-FU/LV or capecitabine).

Results

Of the projected 380 patients, only 32 patient

SUBMITTER: McCleary NJ 

PROVIDER: S-EPMC5757827 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature