Status:
ACTIVE_NOT_RECRUITING
Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Stage II Colon Cancer
Stage III Colon Cancer
Eligibility:
All Genders
19+ years
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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);
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
March 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
2013 Patients enrolled
Trial Details
Trial ID
NCT04416490
Start Date
March 25 2020
End Date
February 1 2027
Last Update
September 12 2025
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea