NCT02376452

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

February 12, 2015

Last Update Submit

March 2, 2015

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    2 months

Secondary Outcomes (5)

  • overall survival

    6 months

  • overall response rate

    2 months

  • disease control rate

    2 months

  • Number of Participants with Adverse Events

    2 months

  • quality of life questionnaire

    2 months

Study Arms (2)

RALIRI

EXPERIMENTAL

Raltitrexed combined with irinotecan

Drug: RaltitrexedDrug: Irinotecan

FOLFIRI

PLACEBO COMPARATOR

5-fluorouracil,folinate combined with irinotecan

Drug: IrinotecanDrug: 5-fluorouracilDrug: Leucovorin

Interventions

RaltitrexedDRUG

2mg/m2 iv gtt, d1

RALIRI
IrinotecanDRUG

180 mg/m2 iv gtt, d1

FOLFIRIRALIRI
5-fluorouracilDRUG

5-FU 400mg/m2 iv, 2400mg/m2 civ 46h

Also known as: 5-FU
FOLFIRI
LeucovorinDRUG

400mg/m2 iv gtt,d1

Also known as: LV
FOLFIRI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

raltitrexedIrinotecanFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Wen Zhang

    Medical Oncology, Fudan University Shanghai Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Zhang

CONTACT

8621-64175590-65242

Wenhua Li

CONTACT

8621-64175590-65197

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fudan University Shanghai Cancer Center

Study Record Dates

First Submitted

February 12, 2015

First Posted

March 3, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

March 3, 2015

Record last verified: 2015-02

Locations

CN(1)