Trial Outcomes & Findings for Study for Inoperable Non-Metastatic Pancreatic CA (Stage IVA) With Neoadjuvant GTX, and Radiation With Gemzar (NCT NCT00869258)

Last Updated: 2016-06-22

Results Overview

Data was not analyzed because original PI left institution before data analysis was completed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

10 weeks

Results posted on

2016-06-22

Participant milestones
Measure	GTX and Radiation Therapy With Gemzar Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
Overall Study STARTED	32
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	GTX and Radiation Therapy With Gemzar Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
Overall Study Physician Decision	1

Study for Inoperable Non-Metastatic Pancreatic CA (Stage IVA) With Neoadjuvant GTX, and Radiation With Gemzar

Baseline characteristics by cohort
Measure	GTX and Radiation Therapy With Gemzar n=32 Participants Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=99 Participants
Age, Categorical >=65 years	12 Participants n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	22 Participants n=99 Participants
Race (NIH/OMB) More than one race	5 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants

Timeframe: 10 weeks

Data was not analyzed because original PI left institution before data analysis was completed.

Outcome data not reported

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events
Measure	GTX and Radiation Therapy With Gemzar n=32 participants at risk Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
Infections and infestations Fever	3.1% 1/32 • Number of events 1
Hepatobiliary disorders Clogged Common Bile Duct (CBD) Stent	3.1% 1/32 • Number of events 1
Gastrointestinal disorders Gastrointestinal (GI) Bleed	3.1% 1/32 • Number of events 1
Gastrointestinal disorders Irritable Bowel	3.1% 1/32 • Number of events 1
Gastrointestinal disorders Gallbladder Issues and Fever	3.1% 1/32 • Number of events 1
Infections and infestations Stent Replacement and Possible Biliary Sepsis	3.1% 1/32 • Number of events 1

Other adverse events
Measure	GTX and Radiation Therapy With Gemzar n=32 participants at risk Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
General disorders Fatigue	3.1% 1/32 • Number of events 1
General disorders Asthenia	3.1% 1/32 • Number of events 1
Infections and infestations Infectious Colitis	3.1% 1/32 • Number of events 1
Infections and infestations Thrush	3.1% 1/32 • Number of events 1
Renal and urinary disorders Abnormal Creatinine Level	3.1% 1/32 • Number of events 1
Metabolism and nutrition disorders Dehydration	3.1% 1/32 • Number of events 1
Metabolism and nutrition disorders Anorexia	3.1% 1/32 • Number of events 1
Gastrointestinal disorders Diarrhea	3.1% 1/32 • Number of events 1
General disorders Dysphagia	3.1% 1/32 • Number of events 1
Gastrointestinal disorders Mucositis	3.1% 1/32 • Number of events 1
Metabolism and nutrition disorders Nausea	3.1% 1/32 • Number of events 1
Blood and lymphatic system disorders Leukopenia	3.1% 1/32 • Number of events 1
Blood and lymphatic system disorders Neutropenia	6.2% 2/32 • Number of events 2

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