Stage II Colon CancerOCEANNCT04416490
Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer
An observational study of Stage II Colon Cancer and Stage III Colon Cancer, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stage II Colon Cancer, Stage III Colon Cancer
- How many people
- 2,013 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2020to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high-risk stage II or stage III primary colon cancer who have received curative resection. Approximately 2,000 subjects.
Who may be able to join
- 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.
- Male and female adult subjects who are ≥ 19 years old.
- 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.
- Cancer is at T4 stage (stage IIB,IIC);
- Cancer cell differentiation grade is 3 or 4 (poor histologic grade);
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- Cancer cells are present in lymphatic or blood vessels around the tumor (peritumoral lymphovascular involvement);
- Ileus was present during surgery (bowel obstruction at presentation);
- 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,
- Cancer cells invaded into the area around the ganglion (perineural invasion).
- Subjects are decided to require adjuvant chemotherapy including oxaliplatin and/or capecitabine after curative resection (E.g.: FOLFOX, CapeOx or Capecitabine and modified therapies).
- Subjects' performance status score (ECOG PS) is 2 or lower (0, 1, 2).
Who cannot join
- Subjects are diagnosed with other primary cancers that can influence the treatment or prognosis of primary rectal and colon cancers.
- Subjects are diagnosed with relapsed or secondary colon cancer.
- Subjects with Stage 0/1 (Tis/1/2, N0M0) or Stage IV (any T, any N, M1) colon cancer.
- Subjects who are currently on adjuvant chemotherapy after curative resection.
- Subjects who are receiving palliative chemotherapy.
- Pregnant and breast-feeding subjects.
- 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.
- Other subjects who are not suitable for study participation upon the investigator's decision.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: 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.
Read the 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.
- Conditions
- Stage II Colon Cancer, Stage III Colon Cancer
- Keywords
- colon cancer, high-risk stage, curative resection, adjuvant chemotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with high-risk stage II or stage III primary colon cancer who have received curative resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of adjuvant chemotherapy
Type of adjuvant chemotherapy that were used.
Measured: through adjuvant chemotherapies completion, an average of 24 weeks
Frequency of adjuvant chemotherapy
Frequency of adjuvant chemotherapy that were used.
Measured: 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 from the date of resection surgery to the date of first relapse,
Measured: From date of resection surgery until the date of first documented progression, assessed up to 36 months
Overall Survival (OS)
Time from the date of resection surgery to the date of death.
Measured: From date of resection surgery until the date of death, assessed up to 36 months
Secondary outcomes (3)
Characteristics of relapsed and metastasis cancers and new primary malignant tumor list.
Whether locally relapsed, whether metastasis is present, location of metastasis, etc.
Measured: up to 36 months
Quality of Life Assessment (FACT-C)
Subjects will be asked to complete questionnaires to evaluate their quality of life
Measured: 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)
Subjects will be asked to complete questionnaires to evaluate their quality of life
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start25 Mar 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Colon CancerStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Sook Hong, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416490
- Sponsor's protocol ID
- BR-OXP-OS-401
- Acronym
- OCEAN
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2020
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04416490
- Acronym / sponsor ID
- OCEAN / BR-OXP-OS-401
- Conditions
- Stage II Colon Cancer, Stage III Colon Cancer
- Keywords
- colon cancer, high-risk stage, curative resection, adjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,013 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with high-risk stage II or stage III primary colon cancer who have received curative resection |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high-risk stage II or stage III primary colon cancer who have received curative resection. Approximately 2,000 subjects.
Key inclusion criteria (12 listed)
- 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.
- Male and female adult subjects who are ≥ 19 years old.
- 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).
- Subjects are decided to require adjuvant chemotherapy including oxaliplatin and/or capecitabine after curative resection (E.g.: FOLFOX, CapeOx or Capecitabine and modified therapies).
- Subjects' performance status score (ECOG PS) is 2 or lower (0, 1, 2).
Key exclusion criteria (8 listed)
- Subjects are diagnosed with other primary cancers that can influence the treatment or prognosis of primary rectal and colon cancers.
- Subjects are diagnosed with relapsed or secondary colon cancer.
- Subjects with Stage 0/1 (Tis/1/2, N0M0) or Stage IV (any T, any N, M1) colon cancer.
- Subjects who are currently on adjuvant chemotherapy after curative resection.
- Subjects who are receiving palliative chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of adjuvant chemotherapy
Time frame: through adjuvant chemotherapies completion, an average of 24 weeks
Type of adjuvant chemotherapy that were used.
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.
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,
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.
3 secondary outcomes
Characteristics of relapsed and metastasis cancers and new primary malignant tumor list.
Time frame: 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung Sook Hong study director
Boryung Pharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage II Colon Cancer and Stage III Colon Cancer, run by Boryung Pharmaceutical Co., Ltd at 1 site 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 12 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Type of adjuvant chemotherapy (time frame: through adjuvant chemotherapies completion, an average of 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.