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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer Metastatic

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Trial Information

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


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

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:

Overall Survival

Outcome Description:

To compare the effectiveness of treatment with SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone in terms of overall survival.

Outcome Time Frame:

Time of randomization for an average of two years.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

STX0112

NCT ID:

NCT01721954

Start Date:

February 2013

Completion Date:

July 2014

Related Keywords:

  • Colorectal Cancer Metastatic
  • colon
  • rectum
  • metastatic colorectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Fletcher Allen Health Care Burlington, Vermont  05401
Ochsner Clinic Foundation New Orleans, Louisiana  70121
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Montefiore Medical Center Bronx, New York  10467-2490
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
City of Hope Duarte, California  91010
Roswell Park Cancer Center Buffalo, New York  14263
University of Maryland Medical Center Baltimore, Maryland  21201-1595
Lenox Hill Hospital New York City, New York  10021
Aurora St. Luke's Medical Center Milwaukee, Wisconsin  53215
St. Mark's Hospital Salt Lake City, Utah  84124
University of Illinois Chicago Chicago, Illinois  60607
St. Vincent Health Group Indianapolis, Indiana  46260
Methodist Hospital Dallas Dallas, Texas  75203
West Virginia University Healthcare Morgantown, West Virginia  26506