MINIMALLY INVASIVE SURGERY IN CHILDREN WITH CANCER
Project Number5U01CA065175-03
Contact PI/Project LeaderHOLCOMB, GEORGE W
Awardee OrganizationNATIONAL CHILDHOOD CANCER FOUNDATION
Description
Abstract Text
Minimally invasive surgery (MIS) is being rapidly applied to many adult
and pediatric surgical conditions. The prevailing atmosphere has been
consumer-driven to the point that traditional evaluation processes have
been severely limited or bypassed completely. Most reports are single
author or institutional anecdotal assessments with few controlled
appraisals of safety and efficacy.
New indications within the domain of surgical oncology have been proposed
for MIS which would supplant the standard open thoracic and abdominal
procedures. While most of these have been referable to adult patients, the
role of MIS in the management of children with cancer is currently unknown
and must be carefully evaluated.
Because pediatric solid tumors are rare, a large consortium of pediatric
institutions will be required to adequately study this new technology. The
Childrens Cancer Group (CCG) is such a multi-institutional,
multidisciplinary cooperative group which has a long-standing track record
in the successful completion of this type of complex clinical trial. The
CCG Surgery Discipline Committee is well known for its structure,
organization, academic productivity and quality control mechanisms to
support such an effort. Also the committee has a uniquely documented,
broad-based expertise in MIS technology as required by the protocol.
This study proposes to determine the role of MIS in the management of
pediatric cancer by testing three hypotheses: 1) MIS is a safe and
practical procedure in children with cancer; 2) MIS is as efficacious as
standard open surgical operations for the diagnosis, staging and
assessment of resectability of pediatric solid tumors; and 3) MIS will
improve recovery and convalescence of children with cancer and decrease
the cost of care.
The specific aims related to hypothesis #1 will be evaluated in a phase Il
investigation format during year one of the study. If this hypothesis is
validated, the specific goals used to test hypothesis #2 and #3 will be
analyzed in a prospective randomized phase Ill protocol of MIS versus
traditional surgical techniques. This will require approximately two years
to accomplish.
The following proposal is intended to respond to RFA #CA-93-032 and will
outline the significance of the study, experience of the CCG surgeons,
preeminent expertise of the Principal Investigator, research goals and
design, specific study methodology, necessary statistical analyses,
requested budget justification and required supporting documents.
No Sub Projects information available for 5U01CA065175-03
Publications
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