Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Samsung Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Samsung Medical Center
Collaborators:
National Cancer Center, Korea
Seoul National University Bundang Hospital
Seoul National University Hospital
Gachon University Gil Medical Center
Yonsei University
Asan Medical Center
Chonnam National University Hospital
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00677443
First received: May 12, 2008
Last updated: June 22, 2010
Last verified: June 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Primary objective :
To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma.
Secondary objectives :
- To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
- To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: S-1 & Oxaliplatin Drug: Capecitabine & Oxaliplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 344 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | November 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: S-1 and Oxaliplatin
S-1 and Oxaliplatin S-1 : 80 mg/m2/day D1-14 Oxaliplatin : 130 mg/m2/day D1 Repeated every 3 weeks |
Drug: S-1 & Oxaliplatin
S-1 and Oxaliplatin : S-1 80 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
Other Name: S-1 and Oxaliplatin
|
|
Active Comparator: Capecitabine and Oxaliplatin
Capecitabine and Oxaliplatin
|
Drug: Capecitabine & Oxaliplatin
COX : Capecitabine 1000 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
Other Name: Capecitabine and Oxaliplatin
|
Detailed Description:
- The urgent need for new effective therapy with better safety profile for metastatic colorectal cancer patients and promising results observed so far in trials with S-1 combined with oxaliplatin in gastrointestinal cancer including colorectal cancer strongly warrants the comparison of S-1 combined with oxaliplatin to capecitabine combination with oxaliplatin acknowledged as a standard regimen in a first-line treatment for advanced colorectal cancer patients.
- Recently, a Phase I study was completed, indicating recommended dose as S-1 100 mg/m2/day1-14 and oxaliplatin (130 mg/m2/day1), repeated every 3 weeks. However, in the phase II study using the above recommended dose, delayed toxicities of thrombocytopenia and anemia were observed. These delayed toxicities were also reported in a phase II study using S-1 90 mg/m2/day plus oxaliplatin 130 mg/m2/day1 in advanced gastric cancer. At 2007 GI ASCO, the interim data of S-1(80 mg/m2/day1-14) plus oxaliplatin (130 mg/m2/day1) combination, repeated every 3 weeks, was presented, showing promising antitumor activity with favourable safety profile. Among 18 patients, there were only two patients with Grade 3 thrombocytopenia and one with Grade 3 neutropenia. Response rate was 57.1 % and disease control rate was 92.9 %. Considering these results and Japanese data which showed that enhanced efficacy was not observed with S-1 over 90 mg/m2/day and oxaliplatin combination, S-1 80 mg/m2/day 1-14 and oxaliplatin 130 mg/m2/D1, repeated every 3 weeks, will be tested in this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically documented colorectal adenocarcinoma
- Age over 18 years old
- Performance status (ECOG scale): 0-2
- Measurable or evaluable disease
- Patients can take food and drugs orally
- Adequate organ functions
- Life expectancy ≥ 3 months
- Patients should sign a written informed consent before study entry
Exclusion Criteria:
- Tumor type other than adenocarcinoma
- Second primary malignancy
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer
- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
- Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization.
- Presence of CNS metastasis
- Obvious peritoneal seeding or bowel obstruction disturbing oral intake
- Symptomatic peripheral neuropathy
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. The patient received curative operation or RFA for metastatic disease.
- Serious illness or medical conditions
- Receiving a concomitant treatment with drugs interacting with S-1, capecitabine or oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent phenytoin warfarin etc.
- Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677443
Contacts
| Contact: Young Suk Park, M.D.,Ph.D. | 82-2-3410-3459 | pys27hmo@skku.edu |
| Contact: Joon Oh Park, M.D.,Ph.D. | 82-2-3410-3459 |
Locations
| Korea, Republic of | |
| National Cancer Center | Recruiting |
| Goyang, Gyeonggi, Korea, Republic of, 410-769 | |
| Contact: Yong Sang Hong, M.D. 82-31-920-1893 yshong@ncc.re.kr | |
| Principal Investigator: Yong Sang Hong, M.D. | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam, Gyeonggi, Korea, Republic of | |
| Contact: Jee Hyun Kim M.D.,Ph.D. jhkimmd@snu.ac.kr | |
| Principal Investigator: Jee Hyun Kim, M.D.,Ph.D. | |
| Chonnam National University Hospital | Recruiting |
| Hwasun, Jeollanamdo, 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. | |
| Yeungnam University | Recruiting |
| Daegu, Korea, Republic of, 705-717 | |
| Contact: Kyung Hee Lee, M.D.,Ph.D. 82-53-620-3845 lkhee@med.yu.ac.kr | |
| Principal Investigator: Kyung Hee Lee, M.D.,Ph.D. | |
| Gachon University Gil Medical Center | Recruiting |
| Inchon, Korea, Republic of | |
| Contact: Dong Bok Shin, M.D.,Ph.D. dbs@gilhospital.com | |
| Principal Investigator: Dong Bok Shin, M.D.,Ph.D. | |
| Yonsei University | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Joong Bae Ahn, M.D.,Ph.D. vvswm513@yuhs.ac | |
| Principal Investigator: Joong Bae Ahn, M.D.,Ph.D. | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Tae Won Kim, M.D.,Ph.D. 82-2-3010-3910 twkimmd@amc.seoul.kr | |
| Principal Investigator: Tae Won Kim, M.D.,Ph.D. | |
| Soon Chun Hyang University Hospital | Recruiting |
| Seoul, Korea, Republic of, 140-743 | |
| Contact: Namsu Lee, M.D.,Ph.D. 82-2-709-9483 mdnslee@hosp.sch.ac.kr | |
| Principal Investigator: Namsu Lee, M.D.,Ph.D. | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Tae-Yoo Kim, M.D.,Ph.D. kimty@snu.ac.kr | |
| Principal Investigator: Tae-Yoo Kim, M.D.,Ph.D. | |
| Samsung Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Young Suk Park, M.D.,Ph.D. 82-2-3410-3459 pys27hmo@skku.edu | |
| Contact: Se Hoon Park, M.D. 82-2-3410-1767 hematoma@skku.edu | |
| Principal Investigator: Young Suk Park, M.D.,Ph.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: Jeeyun Lee, M.D.,Ph.D. | |
| Sub-Investigator: Se Hoon Park, M.D.,Ph.D. | |
| Korea Cancer Center Hospital | Recruiting |
| Seoul, Korea, Republic of, 139-706 | |
| Contact: Hye Jin Kang, M.D.,Ph.D. 82-2-970-1289 hyejin@kcch.re.kr | |
| Principal Investigator: Hye Jin Kang, M.D.,Ph.D. | |
Sponsors and Collaborators
Samsung Medical Center
National Cancer Center, Korea
Seoul National University Bundang Hospital
Seoul National University Hospital
Gachon University Gil Medical Center
Yonsei University
Asan Medical Center
Chonnam National University Hospital
Investigators
| Study Chair: | Young Suk Park, M.D.,Ph.D. | Samsung Medical Center, Seoul, Korea |
| Principal Investigator: | Hye Jin Kang, M.D.,Ph.D. | Korea Cancer Center Hospital , Seoul, Korea |
| Principal Investigator: | Jee Hyun Kim, M.D.,Ph.D. | Seoul National University Bundang Hospital, Gyeonggi, Korea |
| Principal Investigator: | Tae Won Kim, M.D.,Ph.D. | Asan Medical Center, Seoul, Korea |
| Principal Investigator: | Tae-Yoo Kim, M.D.,Ph.D. | Seoul National University Hospital , Seoul, Korea |
| Principal Investigator: | Dong Bok Shin, M.D.,Ph.D. | Gil Medical Center, Gyeonggi, Korea |
| Principal Investigator: | Joong Bae Ahn, M.D.,Ph.D. | Yonsei Medical Center, Severance Hospital, Seoul, Korea |
| Principal Investigator: | Kyung Hee Lee, M.D.,Ph.D. | Yeungnam University College of Medicine , Daegu, Korea |
| Principal Investigator: | Namsu Lee, M.D.,Ph.D. | Soon Chun Hyang University Hospital , Seoul, Korea |
| Principal Investigator: | Ik-Joo Chung, M.D.,Ph.D. | Chonnam National University Hwasun Hospital, Jeollanamdo, Korea |
| Principal Investigator: | Yong Sang Hong, M.D.,Ph.D. | National Cancer Center, Gyeonggi, Korea |
More Information
No publications provided
| Responsible Party: | Young Suk Park M.D.,Ph.D. Professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00677443 History of Changes |
| Other Study ID Numbers: | 2008-03-012 |
| Study First Received: | May 12, 2008 |
| Last Updated: | June 22, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Samsung Medical Center:
|
metastatic colorectal cancer S-1 Capecitabine Oxaliplatin non-inferiority study |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin |
Capecitabine Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013