GCC 0319: A Phase I/II Study of Low-Dose Upper Abdominal Radiation Therapy (UART) or Whole (W) ART as Chemosensitizer in Patients With Locally Advanced or Metastatic Tumors of the Gastrointestinal Tract or Ovary
Before entering this study the doctor will examine the patient and order blood tests. These
tests will use approximately 10 ml of blood. Blood work should be done within 3 weeks prior
to treatment.. Women of child-bearing potential are required to have a pregnancy test done
within 7 days prior to the start of treatment . A CT or a PET/CT scan of the chest, abdomen
and pelvis will be done within 4 weeks prior to starting treatment . All subjects
participating in this study will receive radiation therapy and chemotherapy. Patients will
get 4 cycles of chemotherapy along with radiation. Each cycle of chemotherapy consists of
gemcitabine given i.v. on day 1 and day 8 of treatment. XRT is given on days 1 and 2 and on
days 8 and 9 twice a day. This works out to 8 treatments of XRT per course of chemo.
Overall, a total of 32 treatments of radiation therapy will be given during the 4 sessions
of chemotherapy. Blood work for CBC with differential and platelets will be done prior to
each dose of chemotherapy.The investigational portion of this study is the radiation therapy
given to the abdomen on the same day and the day after the patient receives chemotherapy.
Three-Four weeks after treatment completion the patient will be evaluated again. The
treating physician will examine the patient and order blood tests. These tests will use
approximately 10 ml of blood. The physician will also order a repeat CT or PET/CT to compare
the disease status after treatment. These tests are not experimental and are part of routine
check-ups of patients with pancreatic cancer. Patients will be followed for survival.
Protected health information will not be reviewed by someone other than the patient's
provider to identify potential subjects.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary goal of the Phase I aspect of this study is to determine the maximally tolerated dose (MTD) schedule of low dose UART or WART with 4 cycles of fixed systemic doses of gemcitabine.
William Regine, MD
Chair - University of Maryland
United States: Institutional Review Board
|University of Maryland & Baltimore VA medical centre||Baltimore, Maryland 21201|