NCT01460589Active, not recruitingPhase 3
Early Commencement of Adjuvant Chemotherapy for Colon Cancer
Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
This study sets up the final study end point and three detailed goals as the following. The main objective of study: This trial is done to assess the safety and benefit of early adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional commencement after 2weeks for treatment of patients with colon cancer. Detailed goal of study: The primary endpoint: This study is designed to assess whether early commencement of adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate. The secondary endpoint: This study aims to compare short-term cumulative complications between early and conventional commencement of adjuvant chemotherapy after laparoscopic resection of colon cancer. This study will also assess the quality of life and side effects of chemotherapy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 303 (actual)
- First submitted
- 25 Oct 2011
- Start date
- Jan 2013
- Primary completion date
- Jun 2024
- Lead sponsor
- Kyungpook National University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT01460589
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 303
- From Jan 2013 to the primary completion date, Jun 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- relative or absolute contraindications of chemotherapy
- Recent MI, CVA, nitrate medication
- The concurrent presence of other severe medical diseases
Other illness
- A past history of chemotherapy
- tumor with obstruction or perforation
- Severe cardiovascular disease, psychiatric disease
Other
- An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
- tumor with distant metastases
- synchronous tumor
- Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
- Renal dysfunction (Cr ≥2mg/dl)
Who the study is looking for
- Eligibility rule of enrollment
- Rectal adenocarcinoma that were 15 cm or more from the anal verge
- pathologically diagnosed stage II or III disease
- patients who meet the discharge criteria within 10days after surgery
- Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jun Seok Park Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Kyungpook National University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.