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Note: This record shows only 22 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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EUCTR |
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Last refreshed on:
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14 August 2012 |
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Main ID: |
EUCTR2008-003737-25-IT |
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Date of registration:
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07/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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RANDOMISED COMPARATIVE STUDY OF FOLFOX6m PLUS SIR-SPHERES MICROSPHERES VERSUS FOLFOX6m ALONE AS FIRST LINE TREATMENT IN PATIENTS WITH NONRESECTABLE LIVER METASTASES FROM PRIMARY COLORECTAL CARCINOMA - SIRFLOX study
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Scientific title:
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RANDOMISED COMPARATIVE STUDY OF FOLFOX6m PLUS SIR-SPHERES MICROSPHERES VERSUS FOLFOX6m ALONE AS FIRST LINE TREATMENT IN PATIENTS WITH NONRESECTABLE LIVER METASTASES FROM PRIMARY COLORECTAL CARCINOMA - SIRFLOX study |
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Date of first enrolment:
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19/01/2011 |
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Target sample size:
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318 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003737-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: DM + CHEMIO versus SOLO CHEMIO
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Phase:
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Countries of recruitment
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Germany
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Italy
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Willing and able to provide written informed consent.
- Histologically confirmed adenocarcinoma of the colon or rectum OR radiological evidence of carcinoma of the colon or rectum. - Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of trial entry - Limited extra-hepatic metastases in the lung and/or abdominal lymph nodes are permitted. Metastases in the lung must be not more than five nodules in number with no nodule more than 1 cm in diameter. Involvement of abdominal lymph nodes are permitted provided they measure less than 2 cm in diameter. - Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. - Prior chemotherapy for metastatic colorectal cancer is not allowed. Patients may have received both adjuvant chemotherapy and/or radiotherapy following resection of the primary colorectal cancer, provided the last dose of chemotherapy and/or radiotherapy was administered at least 6 months prior to entry into this study. - WHO performance status 0 - 1 - Adequate haematological, renal and hepatic function - Aged 18 years or older. - Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception. - Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception. - Life expectancy of at least 3 months without any active treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment. - Any extra-hepatic metastases other than (a) lung metastases that are not more than five nodules in number with no nodule more than 1 cm in diameter and (b) involvement of abdominal lymph nodes that measure less than 2 cm in diameter. - Previous radiotherapy delivered to the upper abdomen. - Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. - Equivocal, immeasurable, or unevaluable metastases in the liver. - Peripheral neuropathy > grade 1 (NCI-CTCv3). - Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy. - Previous chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before the documentation of metastatic disease. - Pregnant or breast feeding. - Other active malignancy.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Non-resectable liver metastasis from primary colorectal carcinoma
MedDRA version: 9.1
Level: LLT
Classification code 10052362
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Intervention(s)
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Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Oxaliplatin
Concentration type: equal
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Oxaliplatin
Concentration type: equal
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Calcium folinate
Concentration type: equal
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Calcium folinate
Concentration type: equal
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracil
Concentration type: equal
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracil
Concentration type: equal
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracil
Concentration type: equal
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracil
Concentration type: equal
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Yttrium-90
Current Sponsor code: SIR-Spheres
Concentration unit: GBq gigabecquerel(s)
Concentration type: equal
Concentration number: 4-
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Primary Outcome(s)
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Main Objective: The primary outcome of this study is improvement of the progression free survival.
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Primary end point(s): The primary outcome of this study is progression free survival. Progression-free survival (PFS) is defined as the time interval between randomisation and the date of tumour progression.
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Secondary Objective: Progression free survival in the liver; Overall survival; Tumour response rate (liver ? any site); Hepatic and extra-hepatic recurrence rate; Quality of life; Toxicity and Safety; Liver resection rate;
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Secondary ID(s)
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STX0206
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2008-003737-25-DE
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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