Know Cancer

or
forgot password

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

Thank you

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 Systems Grand Forks, North Dakota  58201
Ingalls Memorial Hospital Harvey, Illinois  60426
Virginia Piper Cancer Institute Minneapolis, Minnesota  55407
William Beaumont Hospital Royal Oak, Michigan  48073
Carolinas Medical Center Charlotte, North Carolina  28232-2861
NorthEast Oncology Associates Concord, North Carolina  28025
University of Illinois at Chicago Chicago, Illinois  60612
Carolinas Hematology-Oncology Associates Charlotte, North Carolina  28203
Montefiore Medical Center Bronx, New York  10467-2490
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
University of Washington Seattle, Washington  98195
University of Louisville Louisville, Kentucky  40202
Weiss Memorial Hospital Chicago,, Illinois  60640
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania  15232
Utah Cancer Specialists Salt Lake City, Utah  84106
University of Maryland Medical Center Baltimore, Maryland  21201-1595
Holy Name Hospital Teaneck, New Jersey  07666
Mecklenburg Medical Group Charlotte, North Carolina  
Greenbaum Cancer Center Baltimore, Maryland  21201-1595
Aurora St. Luke's Medical Center Milwaukee, Wisconsin  53215
Pinnacle Oncology Hematology Scottsdale, Arizona  85258
City of Hope Hospital Duarte, California  91010
Florida International University College of Medicine Practice North Miami Beach, Florida  33169
Vanguard Health Berwyn, Illinois  60402
Adventist Hinsdale Hospital Hinsdale, Illinois  60525
Levine Cancer Institute Charlotte, North Carolina  28211
Carolinas Hematology-Oncology Associates - Ballantyne Charlotte, North Carolina  28277
Carolinas Hematology-Oncology Associates - University Charlotte, North Carolina  28262
Mecklenburg Medical Group - Pineville Charlotte, North Carolina  28210
Mecklenburg Medical Group - South Park Charlotte, North Carolina  28211
Levine Cancer Institute - Blumenthal Cancer Center Charlotte, North Carolina  28204
Carolinas Hematology-Oncology - Ballantyne Charlotte, North Carolina  28277
Mecklenburg Medical Group - Morehead Charlotte, North Carolina  28204
Mecklenburg Medical Group - Carolinas Cancer Associates Monroe, North Carolina  28112
UPMC Cancer Center Beaver Beaver, Pennsylvania  15009
UPMC Cancer Center Arnold Palmer at Mountain View Greensburg, Pennsylvania  15601
UPMC Cancer Center Passavant Pittsburgh, Pennsylvania  15237
UPMC Cancer Center Uniontown Uniontown, Pennsylvania  15401
Utah Cancer Specialists - Bountiful/Lakeview Office Bountiful, Utah  84010
Utah Cancer Specialists - Layton/Davis Office Layton, Utah  84041
Utah Cancer Specialists - Cottonwood Office Murray, Utah  84157
Utah Cancer Specialists - Provo Office Provo, Utah  84604
Utah Cancer Specialists - Salt Lake Clinic Salt Lake City, Utah  84102
St. Mark's Hospital Salt Lake City, Utah  84124
Utah Cancer Specialists - Salt Lake Regional Salt Lake City, Utah  84102
Utah Cancer Specialists - Jordan Valley West Jordan, Utah  84088
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital Milwaukee, Wisconsin  53226