Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Seco... | NCT02376452

Studies
Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients

NCT02376452

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Mar 3, 2015Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Colorectal Carcinoma

Interventions

Raltitrexed
Irinotecan
5-fluorouracil
Leucovorin

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

Feb 2015

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

Sep 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 12, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 3, 2015Estimated

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

Mar 2, 2015

Last Update Posted Date

Mar 3, 2015Estimated

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

This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.

Detailed Description

Not provided

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
RALIRI	Experimental	Raltitrexed combined with irinotecan	Drug: Raltitrexed Drug: Irinotecan
FOLFIRI	Placebo Comparator	5-fluorouracil,folinate combined with irinotecan	Drug: Irinotecan Drug: 5-fluorouracil Drug: Leucovorin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Raltitrexed	Drug	2mg/m2 iv gtt, d1	RALIRI
Irinotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival		2 months

Secondary Outcomes

Measure	Description	Time Frame
overall survival		6 months
overall response rate		2 months
disease control rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
Eastern Cooperative Oncology Group performance status of 0 to 1
life expectancy of ≥ 3 months
patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
patients with symptomatic brain metastases
active clinical severe infection
previously received irinotecan or raltitrexed
dihydropyrimidine dehydrogenase (DPD) enzyme adequate

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
Wen Zhang	Contact	8621-64175590-65242
Wenhua Li	Contact	8621-64175590-65197

Overall Officials

Name	Affiliation	Role
Wen Zhang	Medical Oncology, Fudan University Shanghai Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Hospital	Recruiting	Shanghai	Shanghai Municipality		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
C068874	raltitrexed
D000077146	Irinotecan
D005472	Fluorouracil
D002955	Leucovorin

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D014498	Uracil

Browse Leaves

Not provided

Browse Branches

Not provided