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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00143403
Other study ID # CPT-GMA-301
Secondary ID A5961076
Status Completed
Phase Phase 3
First received September 1, 2005
Last updated September 24, 2010
Start date December 2001
Est. completion date September 2009

Study information

Verified date September 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 321
Est. completion date September 2009
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Irinotecan + 5 FU + folinic acid
irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
Folinic Acid + 5 FU
folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks

Locations

Country Name City State
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Roeselare
Denmark Pfizer Investigational Site Copenhagen
Denmark Pfizer Investigational Site Herlev
Denmark Pfizer Investigational Site Odense
France Pfizer Investigational Site Amiens cedex 1
France Pfizer Investigational Site Avignon
France Pfizer Investigational Site Boulogne Billancourt cedex
France Pfizer Investigational Site Clermont-Ferand Cedex 1
France Pfizer Investigational Site Colmar
France Pfizer Investigational Site Grenoble Cedex 09
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Marseille Cedex 9
France Pfizer Investigational Site Montpellier
France Pfizer Investigational Site Montpellier Cedex 5
France Pfizer Investigational Site Nice
France Pfizer Investigational Site Nimes
France Pfizer Investigational Site Rennes
France Pfizer Investigational Site Strasbourg
France Pfizer Investigational Site Toulouse cedex
Germany Pfizer Investigational Site Cottbus
Germany Pfizer Investigational Site Dessau
Germany Pfizer Investigational Site Erlangen
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Leipzig
Germany Pfizer Investigational Site Magdeburg
Germany Pfizer Investigational Site Magdeburg
Germany Pfizer Investigational Site Mainz
Germany Pfizer Investigational Site Oldenburg
Germany Pfizer Investigational Site Regensburg
Germany Pfizer Investigational Site Tuebingen
Hong Kong Pfizer Investigational Site Hong Kong
Israel Pfizer Investigational Site Haifa
Israel Pfizer Investigational Site Petach-Tikva
Israel Pfizer Investigational Site Rehovot
Israel Pfizer Investigational Site Tel-Aviv
Israel Pfizer Investigational Site Tel-Hashomer
Italy Pfizer Investigational Site Brescia
Italy Pfizer Investigational Site Carpi Modena
Italy Pfizer Investigational Site Latisana, UD
Italy Pfizer Investigational Site Padova
Italy Pfizer Investigational Site Parma
Italy Pfizer Investigational Site Piacenza
Italy Pfizer Investigational Site Reggio Emilia
Italy Pfizer Investigational Site Rozzano (Mi)
Korea, Republic of Pfizer Investigational Site Daegu
Korea, Republic of Pfizer Investigational Site Goyang
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Portugal Pfizer Investigational Site Porto
South Africa Pfizer Investigational Site Panorama Cape Town
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site L'Hospitalet de Llobregat Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Santander Cantabria
Spain Pfizer Investigational Site Sevilla
Sweden Pfizer Investigational Site Goteborg
Switzerland Pfizer Investigational Site Bern
Taiwan Pfizer Investigational Site Taoyuan
Ukraine Pfizer Investigational Site Donetsk
Ukraine Pfizer Investigational Site Kiev
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Southampton
United Kingdom Pfizer Investigational Site Surrey

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Hong Kong,  Israel,  Italy,  Korea, Republic of,  Portugal,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease Free Survival (DFS) time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer. last tumor assessment date or cut-off date, whichever is earlier. No
Secondary Overall Survival Rates Probability of being alive was calculated in a yearly increment. Median follow-up time (42 months) No
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