NCT00482222|UnknownPhase 3DMC

Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer

A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy

University of Southampton ClinicalTrials.gov

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6 other identifiers

CDR0000549541USCTU-4351USCTU-EPOCEUDRACT-2006-003121-82ISRCTN22944367EU-20732

Study Type

interventional

Target

340

Locations

1 country

Sites

Timeline

RegisteredJun 2007

StartedFeb 2007

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.

Trial Health

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Trial Health Score

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

Enrollment

340

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Geographic Reach

1 country

22 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed

7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed

Last Updated

January 23, 2013

Status Verified

April 1, 2008

Enrollment Period

7.8 years

First QC Date

June 4, 2007

Last Update Submit

January 22, 2013

Conditions

Colorectal Cancer Metastatic Cancer

Keywords

adenocarcinoma of the colonstage IV colon canceradenocarcinoma of the rectumstage IV rectal cancerliver metastasesrecurrent colon cancerrecurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

Progression-free survival
end of study

Secondary Outcomes (7)

Response rate before surgery as assessed by RECIST criteria
end of study
Pathological resection status
end of study
Overall survival
end of study
Toxicity
end of study
Quality of life as assessed by the EQ-5D, EORTC QLQ-C30, and EORTC QLQ-LMC21
end of study
+2 more secondary outcomes

Study Arms (2)

OxMdG / IrMdG chemotherapy

ACTIVE COMPARATOR

OxMdG / IrMdG chemotherapy for 12 weeks Followed by surgery OxMdG / IrMdG chemotherapy for 12 weeks

Drug: capecitabineDrug: fluorouracilDrug: leucovorin calciumDrug: oxaliplatinOther: study of socioeconomic and demographic variablesProcedure: adjuvant therapyProcedure: neoadjuvant therapyProcedure: quality-of-life assessment

OxMdG / IrMdG chemotherapy with cetuximab

EXPERIMENTAL

OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks Followed by Surgery OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks

Biological: cetuximabDrug: capecitabineDrug: fluorouracilDrug: leucovorin calciumDrug: oxaliplatinOther: study of socioeconomic and demographic variablesProcedure: adjuvant therapyProcedure: neoadjuvant therapyProcedure: quality-of-life assessment