Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04416490 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer

Study acronym: OCEAN
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv6
  2. Primary and study completion dates: Mar 31, 2026 to Feb 2027 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 2000 to confirmed 2013 · Site details revisedv5 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 2000 to confirmed 2013
    • Site details revised
  3. Trial status: Enrolling by Invitation to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  4. Primary completion date: Mar 25, 2023 to Mar 31, 2026 Completion date: Mar 25, 2025 to Mar 31, 2026v3 Show 1 more changeShow less
    • Completion date: Mar 25, 2025 to Mar 31, 2026
  5. Trial status: Recruiting to Enrolling by Invitation Secondary endpoints revised (3) · Site details revisedv2 Show 2 more changesShow less
    • Secondary endpoints revised (3)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04416490
Lead Sponsor Boryung Pharmaceutical Co., Ltd
Conditions Stage II Colon Cancer, Stage III Colon Cancer
Enrollment 2,013 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov