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Status unknownNCT02376452Updated Mar 3, 2015

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

A Phase 2 interventional study of Raltitrexed and Irinotecan in Colorectal Carcinoma, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-03.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Carcinoma
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    RALIRI

    Raltitrexed combined with irinotecan

    Drug: Raltitrexed · Drug: Irinotecan

  • Placebo comparator
    FOLFIRI

    5-fluorouracil,folinate combined with irinotecan

    Drug: Irinotecan · Drug: 5-fluorouracil · Drug: Leucovorin

Interventions

  • DrugRaltitrexed

    2mg/m2 iv gtt, d1

  • DrugIrinotecan

    180 mg/m2 iv gtt, d1

  • Drug5-fluorouracil

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

    Also known as: 5-FU

  • DrugLeucovorin

    400mg/m2 iv gtt,d1

    Also known as: LV

06

What researchers measure

Primary outcomes

  1. progression free survival

    Time frame: 2 months

Secondary outcomes

  1. overall survival

    Time frame: 6 months

  2. overall response rate

    Time frame: 2 months

  3. disease control rate

    Time frame: 2 months

  4. Number of Participants with Adverse Events

    Time frame: 2 months

  5. quality of life questionnaire

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Fudan University Cancer Hospital
    ShangHai, Shanghai, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02376452
Lead sponsor
Fudan University
Responsible party
Jin Li (Fudan University Shanghai Cancer Center, Fudan University) — Principal investigator
First posted
Mar 3, 2015
Start date
Sep 2014
Primary completion
Dec 2015 (estimated)
Completion
Dec 2016 (estimated)
Last update
Mar 3, 2015

Study contacts

Wen Zhang
Contact
8621-64175590-65242
Wenhua Li
Contact
8621-64175590-65197
Wen Zhang
principal investigator · Medical Oncology, Fudan University Shanghai Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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