Trial Information

The Effect of Neoadjuvant Chemotherapy on Lactate Threshold in Patients With Surgically Resectable Upper Gastrointestinal Cancer.

Purpose: To evaluate the effects of chemotherapy on pre−operative fitness of patients prior
to major cancer surgery.

Design: Patients will act as their own case−control.

Patients will be consented at the earliest available opportunity following the decision that
they have surgically treatable disease and they consent to pre−operative NAC. Consent for
the study will be gained as an outpatient. At "visit 1" patients will undergo CPET, as is
our current standard practice, prior to commencing neoadjuvant chemotherapy. As part of the
assessment, they will have pulmonary function testing (static lung volumes, lung diffusing
capacity),and a nutritional assessment using bioimpedance measurements. They will then
undergo 3 cycles of NAC lasting a total of 6 weeks, as is standard current practice at our
institution. At "visit 2", approximately four to six weeks following chemotherapy and just
prior to planned surgery the CPET and other assessments will be repeated. This is also
current standard practice at our institution.

Data from visit 1 and visit 2 will be compared in a paired manner. A statistician will be
consulted to assess the degree of normality of the data, the statistical tests to use, and
for power calculations. At no point will any treatments be postponed or changed solely for
the purposes of collecting data for the research. 12 months survival will be assessed as an
outcome variable.