Non-resectable liver metastasis from primary colorectal carcinoma MedDRA version: 17.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Eloxatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Oxaliplatin
CAS Number: 63121-00-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Sirtex Technology Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Willing and able to provide written informed consent. - Histologically confirmed adenocarcinoma of the colon or rectum,with or without primary tumour in situ - 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 lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no nodule more than 1 cm in diameter or 1 lesion of up to 1.7cm in diameter. Involvement of lymph nodes in 1 anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm. - Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. - All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation - Prior chemotherapy for metastatic colorectal cancer is not allowed. Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to entry into this study. Radiotherapy to the pelvis is not an exclusion criterion - WHO performance status 0 - 1 - Adequate haematological, renal and hepatic function as follows: Haematological: Neutrophils >1.5 x 10^9/L Platelets >100 x 10^9/L Renal: Creatinine =30 g/L The date of blood tests must be within 28 days prior to the time of randomisation - 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 443 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 127 ;Inclusion criteria: - Willing and able to provide written informed consent. - Histologically confirmed adenocarcinoma of the colon or rectum,with or without primary tumour in situ - 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 lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no nodule more than 1 cm in diameter or 1 lesion of up to 1.7cm in diameter. Involvement of lymph nodes in 1 anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm. - Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. - All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation - Prior chemotherapy for metastatic colorectal cancer is not allowed. Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to entry into this study. Radiotherapy to the pelvis is not an exclusion criterion - WHO performance status 0 - 1 - Adequate haematological, renal and hepatic function as follows: Haematological: Neutrophils >1.5 x 10^9/L Platelets >100 x 10^9/L Renal: Creatinine =30 g/L The date of blood tests must be within 28 days prior to the time of randomisation - 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 443 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 127 ;Inclusion criteria: - Willing and able to provide written informed consent. - Histologically confirmed adenocarcinoma of the colon or rectum,with or without primary tumour in situ - 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 lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no nodule more than 1 cm in diameter or 1 lesion of up to 1.7cm in diameter. Involvement of lymph nodes in 1 anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm. - Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. - All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation - Prior chemotherapy for metastatic colorectal cancer is not allowed. Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to entry into this study. Radiotherapy to the pelvis is not an exclusion criterion - WHO performance status 0 - 1 - Adequate haematological, renal and hepatic function as follows: Haematological: Neutrophils >1.5 x 10^9/L Platelets >100 x 10^9/L Renal: Creatinine =30 g/L The date of blood tests must be within 28 days prior to the time of randomisation - 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 443 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 127
Exclusion criteria
Exclusion criteria: - Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment. - Previous radiotherapy delivered to the upper abdomen. - Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. - 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. - Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix. - Allergy to non-ionic contrast agents ;Exclusion criteria: - Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment. - Previous radiotherapy delivered to the upper abdomen. - Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. - 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. - Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix. - Allergy to non-ionic contrast agents ;Exclusion criteria: - Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment. - Previous radiotherapy delivered to the upper abdomen. - Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. - 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. - Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix. - Allergy to non-ionic contrast agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome of this study is progression free survival.;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 ;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. Tumour progression in the liver is determined from serial CT scans. Diagnosis of tumour recurrence (progression of disease) should be made by using RECIST Criteria. The documented date of recurrence will be the date of confirmation of the recurrence. At the time of recurrence, the investigator should clearly indicate the site of tumour recurrence (hepatic or extra-hepatic). ;Timepoint(s) of evaluation of this end point: End of Trial;Main Objective: The primary outcome of this study is progression free survival.;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 ;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. Tumour progression in the liver is determined from serial CT scans. Diagnosis of tumour recurrence (progression of disease) should be made by using RECIST Criteria. The documented date of recurrence will be the date of confirmation of the recurrence. At the time of recurrence, the investigator should clearly indicate the site of tumour recurrence (hepatic or extra-hepatic). ;Timepoint(s) of evaluation of this end point: End of Trial;Main Objective: The primary outcome of this study is progression free survival.;Secondary Objective: Progression f | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Patients will be followed until death and treatment arms compared by assessment of: Progression free survival in the liver Overall survival Tumour response rate (liver ± any site) Hepatic and extra-hepatic recurrence rate Quality of life Liver resection rate Toxicity and safety;Timepoint(s) of evaluation of this end point: End of Trial;Secondary end point(s): Patients will be followed until death and treatment arms compared by assessment of: Progression free survival in the liver Overall survival Tumour response rate (liver ± any site) Hepatic and extra-hepatic recurrence rate Quality of life Liver resection rate Toxicity and safety;Timepoint(s) of evaluation of this end point: End of Trial;Secondary end point(s): Patients will be followed until death and treatment arms compared by assessment of: Progression free survival in the liver Overall survival Tumour response rate (liver ± any site) Hepatic and extra-hepatic recurrence rate Quality of life Liver resection rate Toxicity and safety;Timepoint(s) of evaluation of this end point: End of Trial | — |
Countries
Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Spain, United States
Contacts
Public ContactDir.Clin.Affair.EU,Midd.East,Africa;Dir.Clin.Affair.EU,Midd.East,Africa;Dir.Clin.Affair.EU,Midd.East,Africa ;;
Sirtex Technology Germany GmbH;Sirtex Technology Germany GmbH;Sirtex Technology Germany GmbH
Outcome results
None listed