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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00006479 |
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Date of registration:
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06/11/2000 |
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Primary sponsor: |
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Public title:
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Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
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Scientific title:
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Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study |
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Date of first enrolment:
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September 2000 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00006479 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Austria
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Belgium
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France
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Germany
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Hong Kong
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Italy
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Netherlands
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New Zealand
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Norway
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Portugal
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Sweden
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United Kingdom
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Contacts
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Name:
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Wolf O. Bechstein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Arbeitsgruppe Lebermetastasen und Tumoren |
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Name:
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Bernard Nordlinger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Ambroise Pare |
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Name:
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Philippe Rougier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Ambroise Pare |
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Name:
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Euan T. Walpole, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Princess Alexandra Hospital |
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Name:
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John N. Primrose, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Southampton NHS Foundation Trust. |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of potentially resectable colorectal liver metastases that meets one of the
following criteria:
- Metachronous metastases after complete resection of primary tumor without gross
or microscopic evidence of residual disease
- Synchronous metastases after complete resection of primary tumor more than 1
month before study
- Synchronous metastases with sufficient evidence (i.e., CAT scan or diagnostic
laparoscopy) that both the primary tumor and liver metastases can be completely
resected during the same procedure and resection of primary may be delayed 3-4
months
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- WHO 0-2
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- No hepatic insufficiency
Renal:
- Creatinine less than 2 times upper limit of normal
Cardiovascular:
- No uncontrolled congestive heart failure or angina pectoris
- No hypertension or arrhythmia
Other:
- No other malignancy within the past 10 years except adequately treated carcinoma in
situ of the cervix or nonmelanoma skin cancer
- No peripheral neuropathy greater than grade 1
- No prior significant neurologic or psychiatric disorders
- No active infection
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- No prior chemotherapy for advanced disease
- Prior adjuvant chemotherapy for primary cancer allowed unless included oxaliplatin
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent anticancer endocrine therapy
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since prior investigational drugs
- No concurrent investigational drugs
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Metastatic Cancer
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Intervention(s)
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Drug: fluorouracil
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Drug: FOLFOX regimen
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Drug: leucovorin calcium
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Drug: oxaliplatin
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Procedure: adjuvant therapy
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Procedure: conventional surgery
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Procedure: neoadjuvant therapy
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Secondary ID(s)
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AGITG-EORTC-40983
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ALM-CAO-EORTC-40983
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CDR0000068309
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CRC-EORTC-40983
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CRUK-LON-EORTC-40983
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EORTC-40983
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EU-20048
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FFCD-EORTC-40983
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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