Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer

Active, not recruiting

• Conditions: Stage II Colon Cancer; Stage III Colon Cancer

• Registration Number: NCT04416490
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-4-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 2013

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Subjects are given explanations about the study objectives and methods, and will<br> express their consent by signing a written agreement to use their personal<br> information.<br><br> 2. Male and female adult subjects who are = 19 years old.<br><br> 3. Subjects are confirmed to have primary colon cancer through histological diagnosis<br> and are at *high-risk stage II (T3/4, N0M0) or stage III (any T, N1/2, M0).<br><br> - High-risk stage II is determined when one or more of the following are<br> applicable.<br><br> 1. Cancer is at T4 stage (stage IIB,IIC);<br><br> 2. Cancer cell differentiation grade is 3 or 4 (poor histologic grade);<br><br> 3. Cancer cells are present in lymphatic or blood vessels around the tumor<br> (peritumoral lymphovascular involvement);<br><br> 4. Ileus was present during surgery (bowel obstruction at presentation);<br><br> 5. Cancer is at T3 stage with localized perforation or there are<br> indeterminate cancer cells residual on the incisal surface. (T3 lesions<br> with localized perforation or close, indeterminate, or positive margins);<br> or,<br><br> 6. Cancer cells invaded into the area around the ganglion (perineural<br> invasion).<br><br> 4. Subjects are decided to require adjuvant chemotherapy including oxaliplatin and/or<br> capecitabine after curative resection (E.g.: FOLFOX, CapeOx or Capecitabine and<br> modified therapies).<br><br> 5. Subjects' performance status score (ECOG PS) is 2 or lower (0, 1, 2).<br><br>Exclusion Criteria:<br><br> 1. Subjects are diagnosed with other primary cancers that can influence the treatment<br> or prognosis of primary rectal and colon cancers.<br><br> 2. Subjects are diagnosed with relapsed or secondary colon cancer.<br><br> 3. Subjects with Stage 0/1 (Tis/1/2, N0M0) or Stage IV (any T, any N, M1) colon cancer.<br><br> 4. Subjects who are currently on adjuvant chemotherapy after curative resection.<br><br> 5. Subjects who are receiving palliative chemotherapy.<br><br> 6. Pregnant and breast-feeding subjects.<br><br> 7. Subjects who are currently participating in other clinical trials (clinical trials<br> for drugs or medical devices) or are planning to participate in other clinical<br> trials during the duration of this study. However, subjects participating in a<br> noninterventional observational study or a registry study can participate in this<br> study.<br><br> 8. Other subjects who are not suitable for study participation upon the investigator's<br> decision.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type of adjuvant chemotherapy;Frequency of adjuvant chemotherapy;Disease Free Survival (DFS);Overall Survival (OS)

Secondary Outcome Measures

Name	Time	Method
Characteristics of relapsed and metastasis cancers and new primary malignant tumor list.;Quality of Life Assessment (FACT-C);Quality of Life Assessment (FACT/GOG-NTX-12)