Effect Of Preoperative Chemotherapy On Short-Term Outcome... | NCT01278368

Studies
Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection

NCT01278368

Sponsor

Università Vita-Salute San Raffaele

Status

Completed

Last Update Posted

Dec 24, 2012Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Interventions

Pancreatic resection after preoperative chemotherapy
Pancreatic resection

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jan 14, 2011

First Submission Date that Met QC Criteria

Jan 14, 2011

First Posted Date

Jan 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2012

Last Update Posted Date

Dec 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marco Braga, Associate Professor of Surgery, Università Vita-Salute San RaffaelePrincipal Investigator

Lead Sponsor

Università Vita-Salute San RaffaeleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pancreatic resection after preoperative chemotherapy	Procedure	Pancreatic resection after preoperative chemotherapy	Preoperative chemotherapy (PCHT)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative morbidity rate		Postoperative. From 0 to 30 days after discharge

Secondary Outcomes

Measure	Description	Time Frame
Postoperative mortality		Postoperative. From 0 to 30 days after discharge
Length of hospital stay (LOS)		Postoperative. From 0 to 30 days after discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of pancreatic cancer
Preoperative chemotherapy
Pancreatic resection

Exclusion Criteria:

Metastatic disease
ASA score 4

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Braga, MD	Università Vita-Salute San Raffaele	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Raffaele Hospital		Milan	Milan	20132	Italy

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided