Trial Outcomes & Findings for A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas (NCT NCT01240304)

Last Updated: 2019-12-10

Results Overview

This will be determined by the tumor's response to the pre/post-operative treatment so that the tumor can be removed surgically.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

An average of 6 years

Results posted on

2019-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine, Radiation Therapy, Surgery Alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate. Radiation therapy: The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the convention
Overall Study STARTED	10
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine, Radiation Therapy, Surgery n=10 Participants Alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate. Radiation therapy: The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the convention
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: An average of 6 years

Population: Early termination. No subject completed study. No data collected. No data analysis was completed.

This will be determined by the tumor's response to the pre/post-operative treatment so that the tumor can be removed surgically.

Outcome measures

Outcome data not reported

Adverse Events

Gemcitabine, Radiation Therapy, Surgery

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gemcitabine, Radiation Therapy, Surgery n=10 participants at risk Alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate. Radiation therapy: The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the convention
Gastrointestinal disorders abdominal pain	10.0% 1/10 • Number of events 1 • 4 months
Gastrointestinal disorders nausea/vomiting	10.0% 1/10 • Number of events 1 • 4 months
Gastrointestinal disorders constipation	10.0% 1/10 • Number of events 1 • 4 months

Additional Information

Beth Scanlan

University of Arkansas for Medical Sciences

Phone: 501-686-8274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place