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TerminatedNCT01677988Updated Jan 15, 2016Results posted

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

A Phase 2 interventional study of Neo-adjuvant Chemotherapy and Chemoradiation in Adenocarcinoma of Head of Pancreas, sponsored by Medical University of South Carolina. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-15.

Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment

Why this study was terminated
Study was terminated due to low accrual.
Phase
Phase 2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.

02

Conditions studied

  • Adenocarcinoma of Head of Pancreas

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Keywords

  • NEOADJUVANT FOLFIRINOX CHEMOTHERAPY
  • LOCALIZED PANCREATIC HEAD ADENOCARCINOMA
  • RADIATION THERAPY
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 3 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has histologically or cytologically confirmed borderline resectable adenocarcinoma of the pancreas. Patients with islet cell or other neuroendocrine neoplasms are excluded.
  • Borderline resectable disease as outlined in the protocol
  • ≥ 18 years of age.
  • Male or non-pregnant and non-lactating female. If a female patient is of childbearing potential, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
  • If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
  • Patient must not have received prior chemotherapy or radiation for pancreatic cancer and no exposure to systemic chemotherapy.
  • Patient have acceptable blood counts, chemistries \& coagulation at baseline as outlined in the protocol
  • Patient has an ECOG performance status PS 0-1.
  • Patient has been informed about the nature of the study and has agreed to participate in the study and signed the Informed Consent Form prior to participation in any study-related activities.
  • Endoscopic ultrasound (EUS) with FNA for cytology.
  • Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics.

Exclusion criteria

Exclusion Criteria:

  • Patient has localized resectable, locally advanced unresectable or advanced metastatic disease. Patients with adenocarcinoma of the pancreatic body or tail are ineligible.
  • Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Patient has known infection with HIV.
  • Patient has undergone major surgery, other than diagnostic surgery (i.e.surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
  • Prior chemotherapy, immunotherapy or radiation for pancreatic cancer.
  • Patient has a history of allergy or hypersensitivity to the study drugs.
  • Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy.
  • Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine).
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years.
  • Patients must not have clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \< 1 year before randomization.
  • Patients must not have a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
  • Patient is unwilling or unable to comply with study procedures.
  • Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
  • Patients aged > 70
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Chemotherapy, Chemoradiation, Surgery

    Neoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection

    Drug: Neo-adjuvant Chemotherapy · Radiation: Chemoradiation · Procedure: Surgical Resection

Interventions

  • DrugNeo-adjuvant Chemotherapy

    1. Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support. 2. Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team) 1. Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD. 2. Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation.

    Also known as: FOLFIRINOX chemotherapy

  • RadiationChemoradiation

    1. Chemoradiation may be administered at selected approved CTN sites. 2. Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board. 1. Unresectable → Off study. Subsequent treatment per patient's primary MD. 2. Resectable → Continue to Registration #3 for Surgical Resection

  • ProcedureSurgical Resection

    1. Meets criteria for resectable\* →pancreaticoduodenectomy (POD) 2. At time of resection, snap frozen tumor specimen sent for correlative biomarker studies

06

What researchers measure

Primary outcomes

  1. Estimate the R0/R1 Resection Rate

    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.

    Time frame: at time of surgery

Secondary outcomes

  1. Radiographic Tumor Response

    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.

    Time frame: From enrollment to Surgery

  2. Histopathologic Tumor Response

    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.

    Time frame: at the time of surgery

  3. Time to Recurrence:

    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.

    Time frame: 2 years

  4. Overall Survival:

    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.

    Time frame: 2 years

Other outcomes

  1. Feasibility Objective

    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.

    Time frame: From enrollment to end of chemotherapy part of the study

  2. CTC Analysis

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

    Time frame: End of study

  3. CTC Expression

    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.

    Time frame: 2 years

07

Results

Posted Jan 15, 2016

Participant flow

Participant flow — Overall Study
MilestoneChemotherapy, Chemoradiation, Surgery
Started3
Completed1
Not completed2
Withdrew: Lack of efficacy2

Outcome measures

PrimaryEstimate the R0/R1 Resection Rate

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.

Time frame:
at time of surgery
Reported as:
Number · participants
Estimate the R0/R1 Resection Rate
participantsChemotherapy, Chemoradiation, Surgery
R0 resection status1
R1 resection status0
SecondaryRadiographic Tumor Response

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.

Time frame:
From enrollment to Surgery
Reported as:
Number · participants
Radiographic Tumor Response
participantsChemotherapy, Chemoradiation, Surgery
SD before chemoradiation2
PD before chemoradiation1
SD before surgery2
SecondaryHistopathologic Tumor Response

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.

Time frame:
at the time of surgery
Reported as:
Number · grade II responder
Histopathologic Tumor Response
grade II responderChemotherapy, Chemoradiation, Surgery
Histopathologic Tumor Response1
SecondaryTime to Recurrence:

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.

Time frame:
2 years

No measurements were reported for this outcome.

SecondaryOverall Survival:

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.

Time frame:
2 years
Reported as:
Number · days
Overall Survival:
daysChemotherapy, Chemoradiation, Surgery
Overall Survival:256
Other pre-specifiedFeasibility Objective

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.

Time frame:
From enrollment to end of chemotherapy part of the study
Reported as:
Number · participants
Feasibility Objective
participantsChemotherapy, Chemoradiation, Surgery
Feasibility Objective3
Other pre-specifiedCTC Analysis

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

Time frame:
End of study

No measurements were reported for this outcome.

Other pre-specifiedCTC Expression

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.

Time frame:
2 years

No measurements were reported for this outcome.

Adverse events

Collected over Start of treatment to end of treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chemotherapy, Chemoradiation, Surgery—2/3 (66.7%)3/3 (100%)
Most frequent serious events
Most frequent serious events
EventChemotherapy, Chemoradiation, Surgery
bile duct stenosisHepatobiliary disorders1/3
abdominal painGastrointestinal disorders1/3
chillsGeneral disorders1/3
feverGeneral disorders1/3
Most frequent other events
Showing 10 of 26
Most frequent other events
EventChemotherapy, Chemoradiation, Surgery
fatigueGeneral disorders3/3
diarrheaGastrointestinal disorders2/3
nauseaGastrointestinal disorders2/3
vomitingGastrointestinal disorders2/3
painGeneral disorders2/3
anemiaBlood and lymphatic system disorders1/3
leukocytosisBlood and lymphatic system disorders1/3
ear infectionEar and labyrinth disorders1/3
chillsGeneral disorders1/3
feverGeneral disorders1/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Chemotherapy, Chemoradiation, Surgery
<=18 years0
Between 18 and 65 years2
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Chemotherapy, Chemoradiation, Surgery
Female1
Male2
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Chemotherapy, Chemoradiation, Surgery
Hispanic or Latino0
Not Hispanic or Latino3
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Chemotherapy, Chemoradiation, Surgery
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White2
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01677988
Lead sponsor
Medical University of South Carolina
Responsible party
Paul O'Brien (Assistant Professor, Medical University of South Carolina) — Principal investigator
First posted
Sep 3, 2012
Start date
Jul 2012
Primary completion
Oct 2015
Results posted
Jan 15, 2016
Last update
Jan 15, 2016

Study contacts

Paul E. O'Brien, MD
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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