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A Randomized Phase II Study of Perioperative Chemotherapy Plus Bevacizumab Versus Postoperative Chemotherapy Plus Bevacizumab in Patients With Upfront Resectable Hepatic Colorectal Metastases (APPROACH)


Phase 2
20 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer, Liver Metastasis

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Trial Information

A Randomized Phase II Study of Perioperative Chemotherapy Plus Bevacizumab Versus Postoperative Chemotherapy Plus Bevacizumab in Patients With Upfront Resectable Hepatic Colorectal Metastases (APPROACH)


Inclusion Criteria:



- Histologically proven colorectal adenocarcinoma

- With hepatic metastasis and no evidence of extrahepatic metastasis (the liver
metastases must be determined by a hepatic surgeon to be resectable)

- 20~80 years

- ECOG performance status 0 - 1

- Adequate laboratory findings

Exclusion Criteria:

- Prior chemotherapy for metastatic disease

- Prior adjuvant chemotherapy, if administered within 6 months before study entry

- Previous hepatic-directed therapy including hepatic resection and/or ablation,
hepatic arterial infusion therapy, or hepatic radiation therapy

- Uncontrolled medical illnesses including medically uncontrolled infection,
uncontrolled hypertension, unstable angina, symptomatic congestive heart failure,
myocardial infarction within 6 months

- Chronic active hepatitis or cirrhosis

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:

2 years recurrence-free survival (2Y-RFS)

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

4-2012-0166

NCT ID:

NCT01632722

Start Date:

June 2012

Completion Date:

August 2016

Related Keywords:

  • Colorectal Cancer
  • Liver Metastasis
  • colorectal cancer, liver metastasis, bevacizumab, perioperative chemotherapy,postoperative chemotherapy
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis

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