Randomized-controlled trial to assess the safety and efficacy of preoperative chemotherapy in patients with locally advanced colon cancer

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003077
• Lead Sponsor: Kyungpook National University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 April 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 708

Inclusion Criteria

1. Pathologically confirmed colon cancer (adenocarcinoma)
2. Age 20 to 75
2. Eastern Cooperative Oncology Group score 0-2
3. Colon adenocarcinoma that were located above more than 15 cm from the anal verge
4. Clinically diagnosed cT3-4 (AJCC 7th edition) and longitudinal tumor length = 4cm
5. Clinical diagnosis of carcinoma involving a single colon segment
6. Patients with adequate hepatic (bilirubin=1.5×ULN (upper limit of normal)), renal (GFR>50ml/min by Wright or Cockroft formula), and bone marrow (WBC>3.0×109/L, Platelet>100×109/L) function
7. If female and of childbearing potential, must: Have a negative pregnancy test =72hours prior to initiating study and agree to avoid pregnancy during and for 6 months after study treatment
8. If male with a partner of childbearing potential, must: Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
9. No history of chemotherapy
10. Be free of cognitive impairment or psychiatric disease
11. Patient able and willing to provide written informed consent for the study

Exclusion Criteria

1. Rectal cancer located within 15 from the anal verge
2. Tumor removal status by colonoscopy (EMR or ESD)
3. Distant metastasis (Extra-mesocolic LN, liver, lung, peritoneum, or other distant metastasis )
4. Peritonitis from cancer perforation or acute colonic obstruction
*Except, if obstruction is relieved by stent or stoma
5. Potentially unresectable tumor
6. Multiple primary colorectal cancers
7. Familial polyposis, hereditary non-polyposis colorectal cancer
8. Inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
9. Non-adenocarcinoma pathology
10. A past history of chemotherapy or concurrent primary malignancies
11. A past history of the cancer occurring in other body areas than the colon cancer within 5 years (except for a past history of the radical resection due to non-melanomatous skin cancer, or carcinoma in situ and early stage disease with a recurrence risk < 5%)
12. American Society of Anesthesiologists’ physical status classification of IV or V
13. The concurrent presence of other severe medical diseases including uncontrolled angina or recent (<6 months) myocardial infarction
14. An ineligibility to participate in the clinical study based on the judgment of investigators from a legal problem

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse-free survival

Secondary Outcome Measures

Name	Time	Method
overall survival;Pathologic tumor regression grade