Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer (OCEAN)

September 10, 2025 updated by: Boryung Pharmaceutical Co., Ltd

A Prospective Observational Study to Investigate Patients' Prognosis and Patterns of Adjuvant Chemotherapy Use After Curative Resection of Primary Colon Cancer at High-risk Stage II or Stage III

According to general medical guidelines, adjuvant chemotherapy is used after curative resection of high-risk stage II or III primary colon cancer. However, there exist limitations using clinical trial data acquired from highly selected subjects in a controlled environment. For example, patients aged over 70 years old were in many cases excluded from clinical trials resulting in insufficient data on the efficacy of therapies including oxaliplatin in aged patients, and the source data of the medical guidelines did not fully reflect the conditions of Korean patients. In addition, suggestions are continuously being submitted for existing therapies with modified administration periods and methods with the aim to search for the optimum effect over side effects. Discussions are also held on meta analyses results that imply the need to apply slightly different approaches through small groups of patient and disease factors. As there are more diverse adjuvant therapy protocols that can be applied to post-surgery colon cancer patients, it is necessary to figure out the patterns of adjuvant chemotherapies actually used in Korean medical practices. Also, in order to complement the limitation of external validity of the existing base clinical data, a multifaceted exploratory analysis will be conducted by making follow-up observations on patterns, prognosis results, quality of life, adverse effects, etc. of post-surgery adjuvant chemotherapies actually used in around 30 sites in Korea under the noninterventional observational study conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

[Overview] Investigators will obtain voluntary consent for participation in this study from patients with high-risk stage II or stage III colon cancer who require or are planning to receive adjuvant chemotherapy after curative resection. Patients who provided written consent for using their personal information and who satisfy inclusion/exclusion criteria will be given a study enrollment number. Among the predefined study-relevant data, available data on these patients will be collected in the case report forms (CRF) until the study is completed.

[Follow-up observation schedule and the scope of data collection] Since this study is an observational study, data collection in the CRF will be restricted to the data created only from usual treatment practices and there will be no separate test or additional drug administration for the study. However, subjects will be asked to complete questionnaire to evaluate their quality of life at the following time points: baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks). For subjects who drop out from the study or in case of disease event (relapse, metastasis or new primary malignant tumor), the questionnaire will be conducted at the time of drop-out or disease event. Survival of all subjects (including those who drop out from the study or whose disease event is confirmed) will be checked every 6 months after adjuvant chemotherapy started. Among the data created from the subjects on their visits for treatment, the following data will be collected for the purpose of this study.

  • Demographics of the subjects.
  • Colon cancer information (diagnosis information, risk factors, surgery information).
  • Whether or not neoadjuvant chemotherapy was conducted.
  • Underlying disease.
  • Adjuvant chemotherapy information.
  • Other concomitant medication (drugs administered for prevention and treatment of OXLIPN, drugs administered for treatment of Grade 3-4 adverse drug reactions/serious adverse drug reactions related to the chemotherapy).
  • Vital signs, height, and weight.
  • Performance Status evaluation (ECOG PS).
  • Geriatric Assessment (KG-7): for subjects ≥ 65 years old.
  • Quality of Life assessment (FACT-C, FACT/GOG-NTX-12).
  • Laboratory test results.
  • Tumor Marker (CEA, CA 19-9) test results.
  • Molecular genetic test results (MSI [microsatellite instability] and/or MMR [DNA mismatch repair gene], immunohistochemistry test for protein, KRAS, NRAS, BRAF etc.).
  • Colonoscopy/CT results.
  • Disease event (relapse, metastasis or new primary malignant tumor).
  • Survival of subjects.
  • Oxaliplatin-induced Peripheral Neuropathy (OXLIPN): Only when oxaliplatin is administered.
  • Grade 3-4 adverse drug reactions related to chemotherapy (based on CTCAE v.5.0).
  • Serious adverse drug reactions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2013

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with high-risk stage II or stage III primary colon cancer who have received curative resection. Approximately 2,000 subjects.

Description

Inclusion Criteria:

  1. Subjects are given explanations about the study objectives and methods, and will express their consent by signing a written agreement to use their personal information.
  2. Male and female adult subjects who are ≥ 19 years old.

  3. Subjects are confirmed to have primary colon cancer through histological diagnosis and are at *high-risk stage II (T3/4, N0M0) or stage III (any T, N1/2, M0).

    • High-risk stage II is determined when one or more of the following are applicable.

      1. Cancer is at T4 stage (stage IIB,IIC);
      2. Cancer cell differentiation grade is 3 or 4 (poor histologic grade);
      3. Cancer cells are present in lymphatic or blood vessels around the tumor (peritumoral lymphovascular involvement);
      4. Ileus was present during surgery (bowel obstruction at presentation);
      5. Cancer is at T3 stage with localized perforation or there are indeterminate cancer cells residual on the incisal surface. (T3 lesions with localized perforation or close, indeterminate, or positive margins); or,
      6. Cancer cells invaded into the area around the ganglion (perineural invasion).
  4. Subjects are decided to require adjuvant chemotherapy including oxaliplatin and/or capecitabine after curative resection (E.g.: FOLFOX, CapeOx or Capecitabine and modified therapies).
  5. Subjects' performance status score (ECOG PS) is 2 or lower (0, 1, 2).

Exclusion Criteria:

  1. Subjects are diagnosed with other primary cancers that can influence the treatment or prognosis of primary rectal and colon cancers.
  2. Subjects are diagnosed with relapsed or secondary colon cancer.
  3. Subjects with Stage 0/1 (Tis/1/2, N0M0) or Stage IV (any T, any N, M1) colon cancer.
  4. Subjects who are currently on adjuvant chemotherapy after curative resection.
  5. Subjects who are receiving palliative chemotherapy.
  6. Pregnant and breast-feeding subjects.
  7. Subjects who are currently participating in other clinical trials (clinical trials for drugs or medical devices) or are planning to participate in other clinical trials during the duration of this study. However, subjects participating in a noninterventional observational study or a registry study can participate in this study.
  8. Other subjects who are not suitable for study participation upon the investigator's decision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients
Patients with high-risk stage II or stage III primary colon cancer who have received curative resection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Type of adjuvant chemotherapy
Time Frame: through adjuvant chemotherapies completion, an average of 24 weeks
Type of adjuvant chemotherapy that were used.
through adjuvant chemotherapies completion, an average of 24 weeks
Frequency of adjuvant chemotherapy
Time Frame: through adjuvant chemotherapies completion, an average of 12 cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days)
Frequency of adjuvant chemotherapy that were used.
through adjuvant chemotherapies completion, an average of 12 cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days)
Disease Free Survival (DFS)
Time Frame: From date of resection surgery until the date of first documented progression, assessed up to 36 months
Time from the date of resection surgery to the date of first relapse,
From date of resection surgery until the date of first documented progression, assessed up to 36 months
Overall Survival (OS)
Time Frame: From date of resection surgery until the date of death, assessed up to 36 months
Time from the date of resection surgery to the date of death.
From date of resection surgery until the date of death, assessed up to 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Characteristics of relapsed and metastasis cancers and new primary malignant tumor list.
Time Frame: up to 36 months
Whether locally relapsed, whether metastasis is present, location of metastasis, etc.
up to 36 months
Quality of Life Assessment (FACT-C)
Time Frame: Baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Subjects will be asked to complete questionnaires to evaluate their quality of life
Baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Quality of Life Assessment (FACT/GOG-NTX-12)
Time Frame: Baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Subjects will be asked to complete questionnaires to evaluate their quality of life
Baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse drug reactions/serious adverse drug reactions
Time Frame: From the date of adjuvant chemotherapy started until the end of follow-up(36 month)
Overall incidence of grade 3-4 adverse drug reactions/serious adverse drug reactions
From the date of adjuvant chemotherapy started until the end of follow-up(36 month)
Oxaliplatin Induced Peripheral Neuropathy, OXLIPN
Time Frame: From the date of adjuvant chemotherapy started until the end of follow-up(36 month)
Overall incidence of Oxaliplatin Induced Peripheral Neuropathy, OXLIPN
From the date of adjuvant chemotherapy started until the end of follow-up(36 month)
Performance Status (ECOG) evaluation results
Time Frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Frequency and ratio of ECOG evaluation results will be presented by time point.
Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Results on weight
Time Frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Descriptive statistics will be presented for the results of weight by time point.
Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Results on body temperature
Time Frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Descriptive statistics will be presented for the results of body temperature by time point.
Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Results on pulse
Time Frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Descriptive statistics will be presented for the results of pulse by time point.
Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Results on blood pressure
Time Frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
Descriptive statistics will be presented for the results of blood pressure by time point.
Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boryung Pharmaceutical Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Myung Sook Hong, Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BR-OXP-OS-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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