Brief Summary
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.
Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.
Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.
Brief Title
FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
Categories
Completion Date
Completion Date Type
Actual
Conditions
Colorectal Cancer Metastatic
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Willing and able to provide written informed consent
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
* Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, \< 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, \< 2 cm)
* All imaging evidence used as part of the screening process must be within 28 days
* Suitable for either treatment regimen
* WHO performance status 0-1
* Adequate hematological, renal and hepatic function
* Life expectancy of at least 3 months without any active treatment
Exclusion Criteria:
* Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment
* Previous radiotherapy delivered to the liver
* Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
* Peripheral neuropathy \> grade 2 (NCI-CTC)
* Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy
* Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study
* 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 contrast media that would preclude angiography of the hepatic arteries
* Age 18 years or older
* Willing and able to provide written informed consent
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
* Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, \< 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, \< 2 cm)
* All imaging evidence used as part of the screening process must be within 28 days
* Suitable for either treatment regimen
* WHO performance status 0-1
* Adequate hematological, renal and hepatic function
* Life expectancy of at least 3 months without any active treatment
Exclusion Criteria:
* Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment
* Previous radiotherapy delivered to the liver
* Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
* Peripheral neuropathy \> grade 2 (NCI-CTC)
* Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy
* Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study
* 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 contrast media that would preclude angiography of the hepatic arteries
Inclusion Criteria
Inclusion Criteria:
* Age 18 years or older
* Willing and able to provide written informed consent
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
* Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, \< 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, \< 2 cm)
* All imaging evidence used as part of the screening process must be within 28 days
* Suitable for either treatment regimen
* WHO performance status 0-1
* Adequate hematological, renal and hepatic function
* Life expectancy of at least 3 months without any active treatment
* Age 18 years or older
* Willing and able to provide written informed consent
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
* Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, \< 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, \< 2 cm)
* All imaging evidence used as part of the screening process must be within 28 days
* Suitable for either treatment regimen
* WHO performance status 0-1
* Adequate hematological, renal and hepatic function
* Life expectancy of at least 3 months without any active treatment
Gender
All
Gender Based
false
Keywords
colon
rectum
metastatic colorectal cancer
liver metastases
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01721954
Org Class
Industry
Org Full Name
Sirtex Medical
Org Study Id
STX0112
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study
Primary Outcomes
Outcome Description
OS defined as the time interval between the date of randomization and the date of death from any cause.
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
Secondary Outcomes
Outcome Description
PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
Outcome Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.
Outcome Measure
Progression-free Survival
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andreas Kaubisch
Investigator Email
akaubisc@montefiore.org
Investigator Phone
718-920-7100
Categories Mesh Debug
Gastrointestinal (GI) Cancers --- COLORECTAL NEOPLASMS
Gastrointestinal (GI) Cancers --- INTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- COLONIC DISEASES
Digestive System --- COLONIC DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
MeSH Terms
COLORECTAL NEOPLASMS
INTESTINAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
DIGESTIVE SYSTEM DISEASES
GASTROINTESTINAL DISEASES
COLONIC DISEASES
INTESTINAL DISEASES
RECTAL DISEASES