Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer (NCT04416490) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer
South Korea2,013 participantsStarted 2020-03-25
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
. Cancer is at T4 stage (stage IIB,IIC);
. Cancer cell differentiation grade is 3 or 4 (poor histologic grade);
. Cancer cells are present in lymphatic or blood vessels around the tumor (peritumoral lymphovascular involvement);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Type of adjuvant chemotherapy
Timeframe: through adjuvant chemotherapies completion, an average of 24 weeks
2
Frequency of adjuvant chemotherapy
Timeframe: through adjuvant chemotherapies completion, an average of 12 cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days)
3
Disease Free Survival (DFS)
Timeframe: From date of resection surgery until the date of first documented progression, assessed up to 36 months
4
Overall Survival (OS)
Timeframe: From date of resection surgery until the date of death, assessed up to 36 months
. 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,
Exclusion criteria
. 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.