Trial Outcomes & Findings for Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma (NCT NCT01677988)

Last Updated: 2016-01-15

Results Overview

Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

at time of surgery

Results posted on

2016-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy, Chemoradiation, Surgery Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy, Chemoradiation, Surgery Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
Overall Study Lack of Efficacy	2

Baseline Characteristics

Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy, Chemoradiation, Surgery n=3 Participants Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	2 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

PRIMARY outcome

Timeframe: at time of surgery

Population: Only subjects who had surgery were included in the outcome measure data.

Outcome measures

Outcome measures
Measure	Chemotherapy, Chemoradiation, Surgery n=1 Participants Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
Estimate the R0/R1 Resection Rate R0 resection status	1 participants
Estimate the R0/R1 Resection Rate R1 resection status	0 participants

SECONDARY outcome

Timeframe: From enrollment to Surgery

Population: All subjects enrolled and had a response assessment are included in the outcome measure below.

The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.

Outcome measures

Outcome measures
Measure	Chemotherapy, Chemoradiation, Surgery n=3 Participants Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
Radiographic Tumor Response SD before chemoradiation	2 participants
Radiographic Tumor Response PD before chemoradiation	1 participants
Radiographic Tumor Response SD before surgery	2 participants

SECONDARY outcome

Timeframe: at the time of surgery

Population: Only subjects who had surgery were included in this outcome measure.

Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.

Outcome measures

Outcome measures
Measure	Chemotherapy, Chemoradiation, Surgery n=1 Participants Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
Histopathologic Tumor Response	1 grade II responder

SECONDARY outcome

Timeframe: 2 years

Population: The study terminated early, prior to the follow up period being completed. Only one subject had surgery and that subject is still alive at the time of study termination, so time to recurrence cannot be estimated.

Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: The study terminated early, prior to the end of the follow up period for all subjects. At the time of study termination, one subject had expired and the time from enrollment to death for that subject is reported below.

Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.

Outcome measures

Outcome measures
Measure	Chemotherapy, Chemoradiation, Surgery n=1 Participants Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
Overall Survival:	256 days

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to end of chemotherapy part of the study

Population: The number of subjects who had 5-6 doses of neoadjuvant regimen

The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population.

Outcome measures

Outcome measures
Measure	Chemotherapy, Chemoradiation, Surgery n=3 Participants Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
Feasibility Objective	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: End of study

Population: The CTC analysis was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.

To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: The CTC expression endpoint was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.

To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient.

Outcome measures

Outcome data not reported

Adverse Events

Chemotherapy, Chemoradiation, Surgery

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy, Chemoradiation, Surgery n=3 participants at risk Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
Hepatobiliary disorders bile duct stenosis	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Gastrointestinal disorders abdominal pain	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
General disorders chills	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
General disorders fever	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.

Other adverse events

Other adverse events
Measure	Chemotherapy, Chemoradiation, Surgery n=3 participants at risk Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
Blood and lymphatic system disorders anemia	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Blood and lymphatic system disorders leukocytosis	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Ear and labyrinth disorders ear infection	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Gastrointestinal disorders diarrhea	66.7% 2/3 • Number of events 2 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Gastrointestinal disorders nausea	66.7% 2/3 • Number of events 2 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Gastrointestinal disorders vomiting	66.7% 2/3 • Number of events 2 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
General disorders fatigue	100.0% 3/3 • Number of events 3 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
General disorders chills	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
General disorders fever	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
General disorders pain	66.7% 2/3 • Number of events 2 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
General disorders non-cardiac chest pain	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Investigations ALT increased	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Investigations alkaline phosphatase increase	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Investigations AST increased	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Investigations blood bilirubin increase	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Metabolism and nutrition disorders abnormal appetite	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Metabolism and nutrition disorders hyperglycemia	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Metabolism and nutrition disorders hypoalbuminemia	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Metabolism and nutrition disorders hypokalemia	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Nervous system disorders dizziness	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Nervous system disorders syncope	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Psychiatric disorders anxiety	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Psychiatric disorders insomnia	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Respiratory, thoracic and mediastinal disorders dyspnea	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Respiratory, thoracic and mediastinal disorders hiccups	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
Surgical and medical procedures ECRP	33.3% 1/3 • Number of events 1 • Start of treatment to end of treatment. AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.

Additional Information

Paul O'Brien, MD

Medical University of South Carolina

Phone: 843-792-4271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place