Phase I Trial of Dose Escalated IMRT to the Para-aortic Nodes With Concurrent Cisplatin and Amifostine in Locally Advanced Cervical Cancer
This is a Phase I open-label multi-institutional study that will enroll a minimum of 27 and
up to 42 patients with locally advanced cervical cancer (a minimum of 27 will be entered if
all dose levels are explored without reaching a dose limiting toxicity at any level). The
primary objective is to determine the maximum tolerated dose (MTD) of external beam
radiation to the para-aortic lymph nodes using IMRT and amifostine. Patients will be
stratified according to gross tumor volume (GTV) prior to dose escalation.
Within each GTV stratum, the dose escalation will be determined as follows: Accrue 3
patients in the first dose level based on the determined stratum. A Dose Limiting Toxicity
is defined as the development of > Grade 3 acute GI toxicity, per the RTOG acute toxicity
scale. If no DLT is observed at the first dose level, 3 patients will be enrolled at the
next dose level. If one patient experiences DLT at a given dose level, 3 additional
patients will be enrolled at that dose level. If 0 of these 3 additional patients
experience DLT, dosing of the next dose level is begun. If 1 or more of these 3 additional
patients experience DLT at the highest dose level below the maximally administered dose,
this dose becomes the recommended dose. At least 6 patients must be entered at this
recommended dose. The Maximum Tolerated Dose (MTD) is defined as the dose preceding that at
which 2 of 6 patients experience dose limiting toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine.
Jennifer F De Los Santos, MD
University of Alabama at Birmingham
United States: Institutional Review Board
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|