wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanc... | NCT01736904

Studies
wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients

NCT01736904

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Nov 29, 2012Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

wXELIRI regimen
FOLFIRI regimen

Countries

China

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

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Nov 21, 2012

First Submission Date that Met QC Criteria

Nov 26, 2012

First Posted Date

Nov 29, 2012Estimated

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

Nov 26, 2012

Last Update Posted Date

Nov 29, 2012Estimated

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

The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of wXELIRI is not less than FOLFIRI with tolerable toxicity.

Detailed Description

The combination of irinotecan and fluorouracil drugs regimen is frequently used in patients with advanced colorectal cancer. According to the previous data, higher rate of diarrhea was observed in the combination of irinotecan and capecitabine (XELIRI) regimen, compared to the combination of irinotecan and 5-fluorouracil (FOLFIRI) regimen. However, the modified weekly XELIRI regimen, which was investigated in our previous single armed study, show tolerate toxicities compared with FOLFIRI, without compromising efficacy. It is supposed that wXELIRI regimen is no less less than FOLFIRI regimen in efficacy.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FOLFIRI	Active Comparator	FOLFIRI regimen	Drug: FOLFIRI regimen
wXELIRI regimen	Experimental	wXELIRI	Drug: wXELIRI regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
wXELIRI regimen	Drug	irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days	wXELIRI regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival which is calculated from the start of treatment to disease progression or death		eight weeks

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate which includes complete response(CR) and partial response(PR) participants	Objective response rate (ORR)= CR(complete response)+PR(partial response)	eight weeks

Other Outcomes

Measure	Description	Time Frame
Overall survival which is calculated from the start to treatment to the death		eight months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
Age range 18-70 years old
ECOG performance status 0-1
Life expectancy of more than 3 months
Adequate organ function

Exclusion Criteria:

Previous serious cardiac disease
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Pregnant or lactating women
chronic inflammatory bowel disease or intestinal obstruction
Serious uncontrolled diseases and intercurrent infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin Li, PhD,MD	Contact	64175590-5109		fudanlijin@163.com

Overall Officials

Name	Affiliation	Role
Jin Lin, PhD, MD	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Hospital	Recruiting	Shanghai	Shanghai Municipality	200032	China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C480833	IFL protocol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided