Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390182
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2006-10-17
Brief Title:
Low Dose Upper Abdominal Radiation Therapy LD-UART Gemcitabine in Patients With Advanced Unresectable Pancreatic Cancer PC
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
GCC 0319 Low Dose Upper Abdominal Radiation Therapy LD-UART Gemcitabine in Patients With Advanced Unresectable Pancreatic Cancer PC
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GCC0319
Brief Summary:
The purposes of this study are
1 To assess the maximum tolerated dose of low-dose UARTUpper Abdominal Radiation Therapy or WARTWhole Abdominal Radiation Therapy given in combination with standard fixed dose-rate Gemcitabine in patients with advanced gastrointestinal GI or ovarian tumors Phase I
2 To assess response rate and survival in advanced upper GI tumors following completion of therapy Phase II
1 To assess the maximum tolerated dose of low-dose UARTUpper Abdominal Radiation Therapy or WARTWhole Abdominal Radiation Therapy given in combination with standard fixed dose-rate Gemcitabine in patients with advanced gastrointestinal GI or ovarian tumors Phase I
2 To assess response rate and survival in advanced upper GI tumors following completion of therapy Phase II
Detailed Description:
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 PETCT 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 iv 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 chemotherapyThe 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 PETCT 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 patients provider to identify potential subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None