Trials Sponsors Conditions Drugs Pricing

Conditions

Adenocarcinoma of Head of Pancreas

Keywords

NEOADJUVANT FOLFIRINOX CHEMOTHERAPYLOCALIZED PANCREATIC HEAD ADENOCARCINOMARADIATION THERAPY

Outcome Measures

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.
at time of surgery

Secondary Outcomes (4)

Radiographic Tumor Response
From enrollment to Surgery
Histopathologic Tumor Response
at the time of surgery
Time to Recurrence:
2 years
Overall Survival:
2 years

Other Outcomes (3)

Feasibility Objective
From enrollment to end of chemotherapy part of the study
CTC Analysis
End of study
CTC Expression
2 years

Study Arms (1)

Chemotherapy, Chemoradiation, Surgery

EXPERIMENTAL

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 ChemotherapyRadiation: ChemoradiationProcedure: Surgical Resection

Interventions

Neo-adjuvant ChemotherapyDrug

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

Chemotherapy, Chemoradiation, Surgery

ChemoradiationRadiation

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Medical University of South Carolina
Otherlead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Results Point of Contact

Title: Paul O'Brien, MD
Organization: Medical University of South Carolina

Study Officials

Paul E. O'Brien, MD
Medical University of South Carolina
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

3 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 3, 2012

Study Start

July 2012

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (3)

Study Arms (1)

Chemotherapy, Chemoradiation, Surgery

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (3)

Study Arms (1)

Chemotherapy, Chemoradiation, Surgery

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations