Clinical trial NCT00143403: Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
Official title: Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Liver Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.


Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour.
* Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
* Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.

Exclusion Criteria:

* Prior hepatic radiation or resection.
* Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
* Prior chemotherapy for metastatic disease.

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: last tumor assessment date or cut-off date, whichever is earlier.
Secondary outcomes:
measure: Overall Survival Rates
timeFrame: Median follow-up time (42 months)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Roeselare
country: Belgium
facility: Pfizer Investigational Site
city: Copenhagen
country: Denmark
facility: Pfizer Investigational Site
city: Herlev
country: Denmark
facility: Pfizer Investigational Site
city: Odense
country: Denmark
facility: Pfizer Investigational Site
city: Amiens cedex 1
country: France
facility: Pfizer Investigational Site
city: Avignon
country: France
facility: Pfizer Investigational Site
city: Boulogne Billancourt cedex
country: France
facility: Pfizer Investigational Site
city: Clermont-Ferand Cedex 1
country: France
facility: Pfizer Investigational Site
city: Colmar
country: France
facility: Pfizer Investigational Site
city: Grenoble Cedex 09
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 9
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Montpellier Cedex 5
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Nimes
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulouse cedex
country: France
facility: Pfizer Investigational Site
city: Cottbus
country: Germany
facility: Pfizer Investigational Site
city: Dessau
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Regensburg
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: Petach-Tikva
country: Israel
facility: Pfizer Investigational Site
city: Rehovot
country: Israel
facility: Pfizer Investigational Site
city: Tel-Aviv
country: Israel
facility: Pfizer Investigational Site
city: Tel-Hashomer
country: Israel
facility: Pfizer Investigational Site
city: Carpi
country: Italy
facility: Pfizer Investigational Site
state: Modena
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Latisana, UD
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Parma
country: Italy
facility: Pfizer Investigational Site
city: Piacenza
country: Italy
facility: Pfizer Investigational Site
city: Reggio Emilia
country: Italy
facility: Pfizer Investigational Site
city: Rozzano (Mi)
country: Italy
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Goyang
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Panorama
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: L'Hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kiev
country: Ukraine
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
city: Surrey
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: