Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy
This study is currently recruiting participants.
Verified December 2012 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01092481
First received: November 22, 2009
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer |
Drug: oxaliplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- quality of life [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- safety profiles [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 2660 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: FOLFOX_12 or CAPOX_8
6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
|
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.
Other Name: oxaliplatin (modified FOLFOX-6 OR CAPOX)
|
|
Experimental: FOLFOX_6 or CAPOX_4
3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
|
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.
Other Name: oxaliplatin (modified FOLFOX-6 OR CAPOX)
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092481
Contacts
| Contact: Young Suk Park, M.D.,Ph.D. | 82-2-3410-3459 | pys27hmo@skku.edu |
Locations
| Korea, Republic of | |
| Hallym University Medical Center | Recruiting |
| Anyang, Gyeonggi, Korea, Republic of, 431-070 | |
| Contact: Dae Young Zang, M.D., Ph.D 82-31-380-3871 fhdzang@hallym.or.kr | |
| Principal Investigator: Dae Young Zang, M.D., Ph.D | |
| Soon Chun Hyang University Hospital Bucheon | Recruiting |
| Bucheon, Gyeonggi, Korea, Republic of, 420-767 | |
| Contact: Dae Sik Hong, M.D., Ph.D 82-32-621-5104 dshong@schbc.ac.kr | |
| Principal Investigator: Dae Sik Hong, M.D., Ph.D | |
| National Cancer Center | Recruiting |
| Goyang, Gyeonggi, Korea, Republic of, 410-768 | |
| Contact: Sun Young Kim, M.D., Ph.D 82-31-920-1661 cathykimmd@gmail.com | |
| Principal Investigator: Sun Young Kim, M.D., Ph.D | |
| School of Medicine, CHA University | Recruiting |
| Seongnam, Gyeonggi, Korea, Republic of, 463-712 | |
| Contact: Doyeun Oh, M.D., Ph.D 82-31-780-5217 doh@cha.ac.kr | |
| Principal Investigator: Doyeun Oh, M.D., Ph.D | |
| Sungkyunkwan University Masan Samsung Hospital | Recruiting |
| Masan, Gyeongsangnam, Korea, Republic of, 630-522 | |
| Contact: Kyung Tae Park, M.D., Ph.D 82-55-290-6007 pkt@unitel.co.kr | |
| Principal Investigator: Kyung Tae Park, M.D., Ph.D | |
| Pusan National University Yangsan Hospital | Recruiting |
| Yangsan, Gyeongsangnam, Korea, Republic of, 626-770 | |
| Contact: Seong - Geun Kim, M.D., Ph.D 82-55-360-1424 patheny@nate.com | |
| Principal Investigator: Seong - Geun Kim, M.D., Ph.D | |
| Chonnam National University Hwasun Hospital | Recruiting |
| Hwasun, Jeollanam, Korea, Republic of, 519-809 | |
| Contact: Ik Joo Chung, M.D., Ph.D 82-61-379-7632 ijchung@jnu.ac.kr | |
| Principal Investigator: Ik Joo Chung, M.D., Ph.D | |
| Kosin Medical Center | Recruiting |
| Busan, Korea, Republic of, 602-702 | |
| Contact: Seong-Hoon Shin, M.D., Ph.D 82-51-990-6107 ssh1533@hanmail.net | |
| Principal Investigator: Seong-Hoon Shin, M.D., Ph.D | |
| Dong-A University Medical Center | Recruiting |
| Busan, Korea, Republic of, 602-715 | |
| Contact: Hyuk-Chan Kwon, M.D., Ph.D 82-51-240-2887 hckwon@dau.ac.kr | |
| Principal Investigator: Hyuk-Chan Kwon, M.D., Ph.D | |
| Gachon University Gil Hospital | Recruiting |
| Incheon, Korea, Republic of, 405-760 | |
| Contact: Dong Bok Shin, M.D., Ph.D 82-32-460-2187 dbs@ghil.com | |
| Principal Investigator: Dong Bok Shin, M.D., Ph.D | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Tae Won Kim, M.D., Ph.D 82-2-3010-3210 twkimmd@amc.seoul.kr | |
| Principal Investigator: Tae Won Kim, M.D., Ph.D | |
| Seoul St. Mary's hospital, Catholic Univerisity | Recruiting |
| Seoul, Korea, Republic of, 137-701 | |
| Contact: Myung Ah Lee, M.D., Ph.D 82-2-2258-6044 angelamd@catholic.ac.kr | |
| Principal Investigator: Myung Ah Lee, M.D., Ph.D | |
| Soonchunhyang University Hospital | Recruiting |
| Seoul, Korea, Republic of, 140-210 | |
| Contact: Nam Su Lee, M.D., Ph.D 82-2-709-9287 mdnslee@hosp.sch.ac.kr | |
| Principal Investigator: Nam Su Lee, M.D., Ph.D | |
| SMG-SNU Boramae Medical Center | Recruiting |
| Seoul, Korea, Republic of, 156-707 | |
| Contact: In Sil Choi, M.D., Ph.D 82-2-870-2231 hmoischoi@hanmail.net | |
| Principal Investigator: In Sil In Sil, M.D., Ph.D | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Young Suk Park, M.D.,Ph.D. 82-2-3410-3459 pys27hmo@skku.edu | |
| Sub-Investigator: Ho-Kyung Chun, M.D., Ph.D | |
| Sub-Investigator: Woo Yong Lee, M.D., Ph.D | |
| Sub-Investigator: Seong Hyeon Yun, M.D., Ph.D | |
| Sub-Investigator: Hee Cheol Kim, M.D., Ph.D | |
| Sub-Investigator: Yong Beom Cho, M.D. | |
| Sub-Investigator: Haeran Yun, M.D. | |
| Sub-Investigator: Won Ki Kang, M.D., Ph.D | |
| Sub-Investigator: Ho Yeong Lim, M.D., Ph.D | |
| Sub-Investigator: Joon Oh Park, M.D., Ph.D | |
| Sub-Investigator: Se Hoon Park, M.D., Ph.D | |
| Sub-Investigator: Jeeyun Lee, M.D., Ph.D | |
| Yonsei University College of Medicine | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Joong Bae Ahn, M.D., Ph.D 82-2-2228-8134 vvswm513@yuhs.ac | |
| Principal Investigator: Joong Bae Ahn, M.D., Ph.D | |
| Chung-Ang University College of Medicine | Recruiting |
| Seoul, Korea, Republic of, 156-755 | |
| Contact: Joung Soon Jang, M.D., Ph.D 82-2-6299-1427 alsaba@hanmail.net | |
| Principal Investigator: Joung Soon Jang, M.D., Ph.D | |
Sponsors and Collaborators
Samsung Medical Center
Investigators
| Principal Investigator: | Young Suk Park, M.D.,Ph.D. | Samsung Medical Center, Seoul, Korea |
More Information
No publications provided
| Responsible Party: | Young Suk Park, Professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01092481 History of Changes |
| Other Study ID Numbers: | 2009-11-008, 2009-11-008 |
| Study First Received: | November 22, 2009 |
| Last Updated: | December 5, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Samsung Medical Center:
|
Adjuvant FOLFOX or CAPOX Therapy Stage II/III Colon Cancer Adjuvant Therapy |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Colonic Diseases Digestive System Diseases |
Gastrointestinal Diseases Intestinal Diseases Adjuvants, Immunologic Oxaliplatin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013