Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers

The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Liver Metastasis
• Intervention / Treatment: Procedure: Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Satoshi Nagayama, Assistant; Phone Number: +81-75-751-3227; Email: nagayama@kuhp.kyoto-u.ac.jp

Study Locations

• Japan
  • Kyoto, Japan, 606-8507
    • Recruiting
    • Kyoto University Hospital
    • Contact: Satoshi Nagayama, Assistant; Phone Number: +81-75-751-3227; Email: nagayama@kuhp.kyoto-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers.
2. Liver lesions are measurable by spiral CT or SPIO-MRI scans.
3. Extrahepatic lesions include lung metastases which can be resected curatively.
4. Curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
5. No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA
6. No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
7. Performance status (ECOG): 0-1
8. Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.

Exclusion Criteria:

Excluded are cases with conditions as below:

1. Peritoneal or pleural fluid retention to be drained.
2. Multiple malignancies to be treated.
3. Peripheral neural disturbances.
4. Active infectious diseases.
5. Severe watery diarrhea.
6. Mental disturbances.
7. Treatment history of continuous, oral or intravenous steroid therapy.
8. Previous history of ischemic heart diseases.
9. Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
10. Pregnant.
11. Previous history of severe drug-induced allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1	Procedure: Surgery; Liver resection for metastatic liver lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Curative resection rates of liver metastases	2 years after the operations

Secondary Outcome Measures

Outcome Measure	Time Frame
Completion rates of neoadjuvant chemotherapy	2 years after the operation

Collaborators and Investigators

• Sponsor: Kyoto University

Publications and helpful links

General Publications

• Nagayama S, Hasegawa S, Hida K, Kawada K, Hatano E, Nakamura K, Seo S, Taura K, Yasuchika K, Matsuo T, Zaima M, Kanazawa A, Terajima H, Tada M, Adachi Y, Nishitai R, Manaka D, Yoshimura T, Doi K, Horimatsu T, Mitsuyoshi A, Yoshimura K, Niimi M, Matsumoto S, Sakai Y, Uemoto S. Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers. Int J Clin Oncol. 2017 Apr;22(2):316-323. doi: 10.1007/s10147-016-1050-5. Epub 2016 Oct 17.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 14, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Estimate): June 23, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Neoadjuvant chemotherapy; Metastatic liver lesions from colorectal cancers
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: C-206; UMIN000000961