NCT02935764

Brief Summary

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

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

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

October 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

October 4, 2016

Last Update Submit

October 14, 2016

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    2 months

Secondary Outcomes (4)

  • overall survival

    6 months

  • overall response rate

    2 months

  • Number of Participants with Adverse Events

    2 months

  • quality of life questionnaire

    2 months

Study Arms (2)

FOLFIRI

EXPERIMENTAL

5-fluorouracil,folinate combined with irinotecan

Drug: IrinotecanDrug: 5-fluorouracilDrug: Leucovorin

IRINOTECAN

ACTIVE COMPARATOR

irinotecan

Drug: Irinotecan

Interventions

IrinotecanDRUG

180 mg/m2 iv gtt, d1

FOLFIRIIRINOTECAN
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 2
  • 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
  • dihydropyrimidine dehydrogenase (DPD) enzyme adequate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zhang X, Duan R, Wang Y, Liu X, Zhang W, Zhu X, Chen Z, Shen W, He Y, Wang HQ, Huang M, Wang C, Zhang Z, Zhao X, Qiu L, Luo J, Sheng X, Guo W. FOLFIRI (folinic acid, fluorouracil, and irinotecan) increases not efficacy but toxicity compared with single-agent irinotecan as a second-line treatment in metastatic colorectal cancer patients: a randomized clinical trial. Ther Adv Med Oncol. 2022 Jan 13;14:17588359211068737. doi: 10.1177/17588359211068737. eCollection 2022.

    PMID: 35069808DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IrinotecanFluorouracilLeucovorin

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 Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of Department of Medical Oncology, Clinical Professor

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 17, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2019

Last Updated

October 17, 2016

Record last verified: 2016-10