Treatment Outcomes of Hepatic Metastasis After FOLFOX-4 Therapy

NCT00610636 | Unknown Phase 3

• 2 other identifiers: 9100015204NSC94-2314-B002-288
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The role of surgical resection in the subset of patients with resectable hepatic metastases converted from initially non-resectable liver metastasis was still not clearly established. To further explore the oncologic results of surgical versus non-surgical methods for the treatment of this subset of patients, we designed and conducted the present randomized prospective study beginning in 2002. The present study was based on the following arguments against the predominant survival benefits of surgical resection in previous reported series: (1) The initially non-resectable liver metastasis was basically a disseminated disease, even though some metastases were highly responsive to chemotherapy and become resectable; (2) Since the evaluation of resectability was based on the imaging studies, it was difficult to consider the surgical resection as "curative" for the resectable hepatic metastases converted from non-resectable ones, given the limitation of the current imaging stools of high-technology; (3) The resectable hepatic metastases after neoadjuvant chemotherapy might represent a subset of hepatic metastases biologically highly responsive to chemotherapy and the time-to-progression for these metastases might be fairly long after a response. Additionally, these metastases might be also biologically responsive to other cytotoxic or targeted therapies that justified the patients' continuous adoption of non-surgical treatment.

Conditions

Colorectal Cancer

Keywords

FOLFOX-4; neoadjuvant chemotherapy; colorectal cancer; liver metastasis; resectability

Outcome Measures

Primary Outcomes (1)

• Both groups of patients were analyzed with intention-to-treat principle. The primary end-point was time-to-progression. The secondary points were overall survival and surgical morbidity.

  evaluated every 6 months

Secondary Outcomes (1)

• Surgical morbidity, Chemotherapeutic complications

  Evaluated every 6 months

Study Arms (2)

1

EXPERIMENTAL

The patients with secondary resectable colorectal hepatic metastasis undergoing surgery

Procedure: Hepatic resection

2

ACTIVE COMPARATOR

The patients with secondary resectable colorectal hepatic metastasis who underwent continuous chemotherapy

Procedure: Hepatic resection

Interventions

Hepatic resection PROCEDURE

Hepatic resection

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Secondary resectable hepatic metastasis converted by FOLFOX-4 regimen.
• age between 18-80 y/o.
• no extra-hepatic disease
• life expectancy ≥ 3 months
• Karnofsky performance status ≥ 50%.
• WBC count ≥ 4,000/μl, platelet count ≥ 100,000/μl, serum bilirubin ≤ 2.0 mg/dl and normal serum glucose and electrolyte levels.-

You may not qualify if:

• Secondary resectable hepatic metastasis with extra-hepatic disease
• poor liver function including: serum bilirubin \> 2.0 mg/dl, GOT,GPT \>100 U/L
• severe steatosis hepatitis or sinusoidal dilation
• Karnoofsky performance status \<50%.-

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Division of Colorectal Surgery, Department of Surgery , National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Links

• Influence of Neoadjuvant Therapy on the Resectability of Hepatic Metastases From Colorectal Cancers
• Association of MSI, TS, DPD, MVD and EGFR With Chemosensitivity in Stage IV in Colorectal Cancer

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jin-Tung Liang, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Tung Liang, PhD

CONTACT

886-2-23123456; jintung@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: January 1, 2002
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

TW (1)