Trial Outcomes & Findings for MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-Metastatic Pancreatic Cancer (NCT NCT01972919)

NCT ID: NCT01972919

Last Updated: 2025-10-27

Results Overview

This measure will be the number of subjects alive at one and two years following the end of radiation treatment, up to two years and seven weeks.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 1 and 2 years following up to 7 weeks of radiation treatment
• Results posted on: 2025-10-27

Participant Flow

Participant milestones

Measure	Radiation Therapy Plus Chemotherapy MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine. Radiation Therapy: Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction. Concurrent chemotherapy (Gemcitabine, Capecitabine): Gemcitabine 400mg/m\^2 IV weekly x 6 doses. Capecitabine 825 mg/m\^2 by mouth twice daily Monday-Friday on days of radiation use 500 mg tablets.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Measure	Radiation Therapy Plus Chemotherapy n=23 Participants MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine. Radiation Therapy: Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction. Concurrent chemotherapy (Gemcitabine, Capecitabine): Gemcitabine 400mg/m\^2 IV weekly x 6 doses. Capecitabine 825 mg/m\^2 by mouth twice daily Monday-Friday on days of radiation use 500 mg tablets.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 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	3 Participants n=5 Participants
Race (NIH/OMB) White	20 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	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 and 2 years following up to 7 weeks of radiation treatment

This measure will be the number of subjects alive at one and two years following the end of radiation treatment, up to two years and seven weeks.

Outcome measures

Measure	Radiation Therapy Plus Chemotherapy n=23 Participants MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine. Radiation Therapy: Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction. Concurrent chemotherapy (Gemcitabine, Capecitabine): Gemcitabine 400mg/m\^2 IV weekly x 6 doses. Capecitabine 825 mg/m\^2 by mouth twice daily Monday-Friday on days of radiation use 500 mg tablets.
Overall Survival One Year	13 Participants
Overall Survival Two Years	7 Participants

SECONDARY outcome

Timeframe: Baseline and 1 year

Number of participants treated with the proposed dose escalation achieving CR, PR, or SD measured by RECIST 1.1 criteria from magnetic resonance imaging (MRI), positron emission tomography (PET) or computed tomography (SC) scans.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 1 year

This measure will be the mean serum activity of CA19-9 in units/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 1 year

This measure will be the mean serum concentration of CEA in ng/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months post treatment

This measure will be the number of subjects experiencing a serious adverse event or grade three or higher non-serious adverse event by CTCAE v4.03 criteria that is definitely, likely, or possibly attributable to the radiation therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

This measure will be the number of participants whose tumor biopsy is positive for the presence of SMAD 4 protein.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 and 2 years

This measure will be the number of subjects achieving a CR or PR or maintaining SD by RECIST 1.1 criteria one and two years following the end of radiation treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 1 year

This measure is the change from baseline of gross tumor volume for participants achieving a complete response (CR) or partial response (PR) or maintaining stable disease (SD) by RECIST 1.1 criteria.

Outcome measures

Outcome data not reported

Adverse Events

Radiation Therapy Plus Chemotherapy

Serious events: 4 serious events

Other events: 10 other events

Deaths: 16 deaths

Serious adverse events

Measure	Radiation Therapy Plus Chemotherapy n=23 participants at risk MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine. Radiation Therapy: Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction. Concurrent chemotherapy (Gemcitabine, Capecitabine): Gemcitabine 400mg/m\^2 IV weekly x 6 doses. Capecitabine 825 mg/m\^2 by mouth twice daily Monday-Friday on days of radiation use 500 mg tablets.
Gastrointestinal disorders Constipation	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Infections and infestations Bacteremia	8.7% 2/23 • Number of events 2 • Up to two years and seven weeks.
Hepatobiliary disorders Bile duct stenosis	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.

Other adverse events

Measure	Radiation Therapy Plus Chemotherapy n=23 participants at risk MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine. Radiation Therapy: Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction. Concurrent chemotherapy (Gemcitabine, Capecitabine): Gemcitabine 400mg/m\^2 IV weekly x 6 doses. Capecitabine 825 mg/m\^2 by mouth twice daily Monday-Friday on days of radiation use 500 mg tablets.
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Blood and lymphatic system disorders Anemia	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Gastrointestinal disorders Ascites	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Gastrointestinal disorders Diarrhea	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Gastrointestinal disorders Duodenal obstruction	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Gastrointestinal disorders Rotavirus	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Gastrointestinal disorders Gastric dysmotility	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Gastrointestinal disorders liver fibrosis	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Vascular disorders Portal Hypertension	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Metabolism and nutrition disorders Hypokalemia	8.7% 2/23 • Number of events 4 • Up to two years and seven weeks.
Investigations Lymphocyte count decreased	8.7% 2/23 • Number of events 2 • Up to two years and seven weeks.
Investigations Neutrophil count decreased	8.7% 2/23 • Number of events 2 • Up to two years and seven weeks.
Hepatobiliary disorders Portal vein thrombosis	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Infections and infestations Sepsis	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.
Investigations White blood cell decreased	4.3% 1/23 • Number of events 1 • Up to two years and seven weeks.

Additional Information

Beth Erickson, MD

Medical College of Wisconsin

Phone: 414-805-4462

Email: BErickson@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place