High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-12-31

Brief Summary

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A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer

Detailed Description

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Conditions

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Advanced Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Administration of high dose simplified folfiri

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Documented progressive metastatic disease
* Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST)
* WHO performance status of 0 or 1
* Adequate laboratory values of haematology, liverfunction and renal function
* No previous chemotherapy for metastatic colorectal cancer

Exclusion Criteria

* Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years.
* Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
* Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion.
* Active uncontrolled infection
* Other concomitant anticancer agent

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Marc Peeters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2004/195

Identifier Type: -

Identifier Source: org_study_id