Trial Outcomes & Findings for Low Dose Upper Abdominal Radiation Therapy (LD-UART) + Gemcitabine in Patients With Advanced, Unresectable Pancreatic Cancer (PC) (NCT NCT00390182)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

38 participants

Primary outcome timeframe

3 weeks

Results posted on

2020-03-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9) 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.
Overall Study STARTED	38
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra n=38 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=93 Participants
Age, Categorical >=65 years	10 Participants n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	21 Participants n=93 Participants
Region of Enrollment United States	29 participants n=93 Participants
Region of Enrollment Canada	9 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 weeks

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.

Outcome measures

Outcome measures
Measure	Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine n=25 Participants 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 Response	3 participants Interval 2.7 to 23.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for an average of 8 years

Patients with distant mestastases to the liver

Outcome measures

Outcome measures
Measure	Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine n=38 Participants 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.
Percentage of Participants With Distant Mestastases - Liver	63 percentage of participants Interval 45.0 to 78.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for an average of 8 years

Locally advanced/recurrent disease without distant metastases.

Outcome measures

Outcome measures
Measure	Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine n=16 Participants 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.
Time of Advanced/Recurrent Disease Without Distant Metastases.	7.5 months Interval 5.0 to 13.0

Adverse Events

Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra

Serious events: 17 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra n=38 participants at risk
Blood and lymphatic system disorders Hematologic	44.7% 17/38 • Number of events 25

Other adverse events

Other adverse events
Measure	Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra n=38 participants at risk
Infections and infestations Infection - non-neutropenic	10.5% 4/38 • Number of events 4

Additional Information

Nancy Kennedy

University of Maryland Baltimore

Phone: 410-328-2513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place