Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer

Condition(s) studied

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Type of adjuvant chemotherapy — through adjuvant chemotherapies completion, an average of 24 weeks
  Type of adjuvant chemotherapy that were used.
• Frequency of adjuvant chemotherapy — 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) — 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) — 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.

Trial sites (1)

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