Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy

Colon Cancer Clinical Trial

Official title:

A Randomized Phase III Study Investigating the Role of Oxaliplatin Duration (3 Months Versus 6 Months) in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Therapy for Patients With Stage II/III Colon Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01092481
• Other study ID #: 2009-11-008
• Secondary ID: 2009-11-008
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 26, 2010
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.

Description:

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer. In addition, we would like to characterize pharmacogenomic profile associated with toxicities and gene expression profiling to predict the recurrence of colon cancer as parallel study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1580
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Curatively resected, histologically confirmed colon adenocarcinoma

• AJCC/UICC high-risk stage II, stage III colon cancer

• Age over 18 years old

• Performance status (ECOG scale): 0-1

• Adequate major organ functions

• Patients should sign a written informed consent before study entry

Exclusion Criteria:

• Colon cancer other than adenocarcinoma

• Rectal cancer

• R1 or R2 resections

• Other malignancies within the last 5 years

• Symptomatic peripheral sensory neuropathy

• Presence of other serious disease

• Lactating or pregnant women

• Fertile women

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• oxaliplatin
to confirm that first 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang	Gyeonggi
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	Gyeonggi
Korea, Republic of	Dong-A University Medical Center	Busan
Korea, Republic of	Kosin Medical Center	Busan
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Sungkyunkwan University Masan Samsung Hospital	Masan	Gyeongsangnam
Korea, Republic of	School of Medicine, CHA University	Seongnam	Gyeonggi
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University College of Medicine	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's hospital, Catholic Univerisity	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	Yonsei University College of Medicine	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		3 years
Secondary	overall survival		3 years
Secondary	quality of life		3 years
Secondary	safety profiles	Safety will be assessed on the basis of an analysis of adverse events, standard clinical chemistry and hematology findings. Clinical and laboratory toxicities/symptoms will be graded according to the CTCAE 3.0. Adverse events which are not reported in CTCAE 3.0 will be graded as mild, moderate, severe or life threatening.	3 years