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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.
[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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with high-risk stage II or stage III primary colon cancer who have received curative resection |
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| Measure | Description | Time Frame |
|---|---|---|
| Type of adjuvant chemotherapy | Type of adjuvant chemotherapy that were used. | through adjuvant chemotherapies completion, an average of 24 weeks |
| Frequency of adjuvant chemotherapy | 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 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of relapsed and metastasis cancers and new primary malignant tumor list. | Whether locally relapsed, whether metastasis is present, location of metastasis, etc. | up to 36 months |
| Quality of Life Assessment (FACT-C) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reactions/serious adverse drug reactions | 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 |
Inclusion Criteria:
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.
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).
Exclusion Criteria:
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Patients with high-risk stage II or stage III primary colon cancer who have received curative resection. Approximately 2,000 subjects.
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| Name | Affiliation | Role |
|---|---|---|
| Myung Sook Hong | Boryung Pharmaceutical Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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) | 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) |
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 | 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 | 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 | 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 | 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 | 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) |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |