Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer

NCT04416490 | Active Not Recruiting

• 1 other identifier: BR-OXP-OS-401
• Study Type: observational
• Target: 2,013
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stage II Colon Cancer; Stage III Colon Cancer

Keywords

colon cancer; high-risk stage; curative resection; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Characteristics of relapsed and metastasis cancers and new primary malignant tumor list.

  up to 36 months

• Quality of Life Assessment (FACT-C)

  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)

  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)

Other Outcomes (7)

• 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

  From the date of adjuvant chemotherapy started until the end of follow-up(36 month)

• Performance Status (ECOG) evaluation results

  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)

Study Arms (1)

Patients

Patients with high-risk stage II or stage III primary colon cancer who have received curative resection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with high-risk stage II or stage III primary colon cancer who have received curative resection. Approximately 2,000 subjects.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Myung Sook Hong

  Boryung Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: June 4, 2020
• Study Start: March 25, 2020
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

KR (1)