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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Colorectal Carcinoma, Liver Metastases

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Trial Information

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


Inclusion Criteria:



- 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).

- Suitable for either treatment regimen.

- Prior chemotherapy for metastatic colorectal cancer is not allowed.

- WHO performance status 0-1.

- Adequate hematological, renal and hepatic function.

- Age 18 years or older.

- Willing and able to provide written informed consent.

- Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria

- Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor
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 the protocol.

- Peripheral neuropathy > grade 1 (NCI-CTC).

- Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.

- Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for
colorectal cancer is not an exclusion criteria provided that it was completed more
than 6 months before entry into the study.

- Pregnant or breast-feeding.

- Other active malignancy.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

from randomisation until progressive disease is confirmed or upon patient death if disease progression has not been evident at that time

Safety Issue:

No

Principal Investigator

Peter Gibbs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Melbourne Health

Authority:

United States: Food and Drug Administration

Study ID:

STX0206

NCT ID:

NCT00724503

Start Date:

August 2006

Completion Date:

April 2018

Related Keywords:

  • Colorectal Cancer
  • Colorectal Carcinoma
  • Liver Metastases
  • colon cancer
  • Colorectal carcinoma
  • liver metastases
  • SIR-Spheres microspheres
  • yttrium-90
  • FOLFOX
  • bevacizumab
  • metastatic colorectal cancer
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

Name

Location

Altru Health SystemsGrand Forks, North Dakota  58201
Ingalls Memorial HospitalHarvey, Illinois  60426
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
William Beaumont HospitalRoyal Oak, Michigan  48073
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
NorthEast Oncology AssociatesConcord, North Carolina  28025
University of Illinois at ChicagoChicago, Illinois  60612
Carolinas Hematology-Oncology AssociatesCharlotte, North Carolina  28203
Montefiore Medical CenterBronx, New York  10467-2490
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
University of WashingtonSeattle, Washington  98195
University of LouisvilleLouisville, Kentucky  40202
Weiss Memorial HospitalChicago,, Illinois  60640
UPMC Hillman Cancer CenterPittsburgh, Pennsylvania  15232
Utah Cancer SpecialistsSalt Lake City, Utah  84106
University of Maryland Medical CenterBaltimore, Maryland  21201-1595
Holy Name HospitalTeaneck, New Jersey  07666
Mecklenburg Medical GroupCharlotte, North Carolina  
Greenbaum Cancer CenterBaltimore, Maryland  21201-1595
Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Pinnacle Oncology HematologyScottsdale, Arizona  85258
City of Hope HospitalDuarte, California  91010
Florida International University College of Medicine PracticeNorth Miami Beach, Florida  33169
Vanguard HealthBerwyn, Illinois  60402
Adventist Hinsdale HospitalHinsdale, Illinois  60525
Levine Cancer InstituteCharlotte, North Carolina  28211
Carolinas Hematology-Oncology Associates - BallantyneCharlotte, North Carolina  28277
Carolinas Hematology-Oncology Associates - UniversityCharlotte, North Carolina  28262
Mecklenburg Medical Group - PinevilleCharlotte, North Carolina  28210
Mecklenburg Medical Group - South ParkCharlotte, North Carolina  28211
Levine Cancer Institute - Blumenthal Cancer CenterCharlotte, North Carolina  28204
Carolinas Hematology-Oncology - BallantyneCharlotte, North Carolina  28277
Mecklenburg Medical Group - MoreheadCharlotte, North Carolina  28204
Mecklenburg Medical Group - Carolinas Cancer AssociatesMonroe, North Carolina  28112
UPMC Cancer Center BeaverBeaver, Pennsylvania  15009
UPMC Cancer Center Arnold Palmer at Mountain ViewGreensburg, Pennsylvania  15601
UPMC Cancer Center PassavantPittsburgh, Pennsylvania  15237
UPMC Cancer Center UniontownUniontown, Pennsylvania  15401
Utah Cancer Specialists - Bountiful/Lakeview OfficeBountiful, Utah  84010
Utah Cancer Specialists - Layton/Davis OfficeLayton, Utah  84041
Utah Cancer Specialists - Cottonwood OfficeMurray, Utah  84157
Utah Cancer Specialists - Provo OfficeProvo, Utah  84604
Utah Cancer Specialists - Salt Lake ClinicSalt Lake City, Utah  84102
St. Mark's HospitalSalt Lake City, Utah  84124
Utah Cancer Specialists - Salt Lake RegionalSalt Lake City, Utah  84102
Utah Cancer Specialists - Jordan ValleyWest Jordan, Utah  84088
Medical College of Wisconsin/Froedtert Memorial Lutheran HospitalMilwaukee, Wisconsin  53226