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Trial record 3 of 2066 for:    Pancreatic Cancer AND Digestive System Neoplasms

Low Dose Upper Abdominal Radiation Therapy (LD-UART) + Gemcitabine in Patients With Advanced, Unresectable Pancreatic Cancer (PC) (GCC0319)

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ClinicalTrials.gov Identifier: NCT00390182
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland, College Park

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastrointestinal Neoplasms
Ovarian Neoplasms
Intervention Drug: Gemcitabine
Enrollment 38
Recruitment Details All patients with cancer are seen by a multi-discipline clinic (medical, surgical, radiotherapy, etc). The PI or Co-PI identifies eligible candidates and initiates the discussion of research participation.
Pre-assignment Details  
Arm/Group Title Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9)
Hide Arm/Group Description 4 cycles (1 cycle = 21 days): Gemcitabine 1250/m2 given IV Day 1 and Day 8; with concurrent Low Dose Fractionated Radiation Therapy (LDFRT). The total Radiation dose would be 19.2 Gy divided over 32 fractions. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. Radiotherapy given after the initiation of Gemcitabine Days 1,2,8, and 9.
Period Title: Overall Study
Started 38
Completed 33
Not Completed 5
Arm/Group Title Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  73.7%
>=65 years
10
  26.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
17
  44.7%
Male
21
  55.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
United States 29
Canada 9
1.Primary Outcome
Title Overall Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine
Hide Arm/Group Description:
Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
3
2.Other Pre-specified Outcome
Title Percentage of Participants With Distant Mestastases - Liver
Hide Description Patients with distant mestastases to the liver
Time Frame Participants were followed for an average of 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine
Hide Arm/Group Description:
Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63
(45 to 78)
3.Other Pre-specified Outcome
Title Time of Advanced/Recurrent Disease Without Distant Metastases.
Hide Description Locally advanced/recurrent disease without distant metastases.
Time Frame Participants were followed for an average of 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine
Hide Arm/Group Description:
Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: months
7.5
(5 to 13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
Affected / at Risk (%) # Events
Total   17/38 (44.74%)    
Blood and lymphatic system disorders   
Hematologic  [1]  17/38 (44.74%)  25
Indicates events were collected by systematic assessment
[1]
Hematologic toxicities, (combined any WBC, HGB, PLTs, ANC) grade 4 experienced in 17 out of 38 participants.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
Affected / at Risk (%) # Events
Total   4/38 (10.53%)    
Infections and infestations   
Infection - non-neutropenic  1  4/38 (10.53%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, Non-neutropenic
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nancy Kennedy
Organization: University of Maryland Baltimore
Phone: 410-328-2513
EMail: nkennedy@umm.edu
Layout table for additonal information
Responsible Party: Department of Radiation Oncology, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT00390182     History of Changes
Other Study ID Numbers: HP-00042314
First Submitted: October 17, 2006
First Posted: October 19, 2006
Results First Submitted: January 16, 2013
Results First Posted: April 9, 2014
Last Update Posted: April 9, 2014