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.
