NCT01278368

Brief Summary

No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

8.9 years

First QC Date

January 14, 2011

Last Update Submit

December 21, 2012

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Keywords

pancreatic cancer, neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Postoperative morbidity rate

    Postoperative. From 0 to 30 days after discharge

Secondary Outcomes (2)

  • Postoperative mortality

    Postoperative. From 0 to 30 days after discharge

  • Length of hospital stay (LOS)

    Postoperative. From 0 to 30 days after discharge

Study Arms (2)

Preoperative chemotherapy (PCHT)

ACTIVE COMPARATOR

Patients who underwent pancreatic resection after PCHT.

Procedure: Pancreatic resection after preoperative chemotherapy

Control

ACTIVE COMPARATOR

Patient who underwent pancreatic resection without preoperative therapy

Procedure: Pancreatic resection

Interventions

Pancreatic resection after preoperative chemotherapyPROCEDURE

Pancreatic resection after preoperative chemotherapy

Preoperative chemotherapy (PCHT)
Pancreatic resectionPROCEDURE

Pancreatic resection

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of pancreatic cancer
  • Preoperative chemotherapy
  • Pancreatic resection

You may not qualify if:

  • Metastatic disease
  • ASA score 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Hospital

Milan, Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Marco Braga, MD

    Università Vita-Salute San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

January 1, 2003

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 24, 2012

Record last verified: 2012-12

Locations

IT(1)