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AzTrials

Colorectal CancerPhase 3NCT00677443

Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer

A Phase 3 study testing S-1 & Oxaliplatin and Capecitabine & Oxaliplatin in people with Colorectal Cancer, run by Samsung Medical Center at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 : 1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups. 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
S-1 & Oxaliplatin and Capecitabine & Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
11 sitesSouth Korea
Study dates
Jun 2008to Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Yeungnam University

    Daegu, 705-717

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

  • Chonnam National University Hospital

    Hwasun, Jeollanamdo, 519-809

  • Gachon University Gil Medical Center

    Inchon

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

  • Korea Cancer Center Hospital

    Seoul, 139-706

  • Soon Chun Hyang University Hospital

    Seoul, 140-743

  • Seoul National University Hospital

    Seoul

  • Yonsei University

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer

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 :

  1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
  2. To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.
Read the 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.
Being tested
S-1 & Oxaliplatin, Capecitabine & Oxaliplatin
Keywords
metastatic colorectal cancer, S-1, Capecitabine, Oxaliplatin, non-inferiority study
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-1 & OxaliplatinDrug

    Also called 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

  • Capecitabine & OxaliplatinDrug

    Also called Capecitabine and Oxaliplatin

    COX : Capecitabine 1000 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks

Study groups in NCT00677443
Study groupRoleWhat they receive
S-1 and OxaliplatinExperimentalS-1 and Oxaliplatin S-1 : 80 mg/m2/day D1-14 Oxaliplatin : 130 mg/m2/day D1 Repeated every 3 weeks
Receives: Drug: S-1 & Oxaliplatin
Capecitabine and OxaliplatinActive comparatorCapecitabine and Oxaliplatin
Receives: Drug: Capecitabine & Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 9 months

Secondary outcomes (2)

  1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.

    Measured: 24 months

  2. To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2009
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00677443
Sponsor's protocol ID
2008-03-012
Status last verified
Jun 2013
First submitted
12 May 2008
Last updated
14 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • Kim ST, Hong YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Lee JW, Jo SJ, Park YS. S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for the first-line treatment of patients with metastatic colorectal cancer: updated results from a phase 3 trial. BMC Cancer. 2014 Nov 26;14:883. doi: 10.1186/1471-2407-14-883.

    PubMed 25424120

  • Hong YS, Park YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Jo SJ, Lee JW. S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for first-line treatment of patients with metastatic colorectal cancer: a randomised, non-inferiority phase 3 trial. Lancet Oncol. 2012 Nov;13(11):1125-32. doi: 10.1016/S1470-2045(12)70363-7. Epub 2012 Oct 10.

    PubMed 23062232

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing S-1 & Oxaliplatin and Capecitabine & Oxaliplatin in people with Colorectal Cancer, run by Samsung Medical Center at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00677443, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.

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