Early Commencement of Adjuvant Chemotherapy for Colon Cancer (ECTX)
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ClinicalTrials.gov Identifier: NCT01460589 |
Recruitment Status :
Active, not recruiting
First Posted : October 27, 2011
Last Update Posted : June 4, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
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Colon Cancer | Procedure: timing to initiate the adjuvant chemotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 440 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | October 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: early commencement
Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery
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Procedure: timing to initiate the adjuvant chemotherapy
Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours
Other Name: early commencement of chemotherapy |
Active Comparator: conventional commencement
Individuals who initiate the adjuvant chemotherapy after 14 days after surgery
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Procedure: timing to initiate the adjuvant chemotherapy
Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours
Other Name: early commencement of chemotherapy |
- 3-year disease free survival rate [ Time Frame: up to 3 years after operation ]A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
- short-term cumulative surgery-related complications during chemotherapy [ Time Frame: up to 26 weeks after operation ]A comparison of the postoperative recovery variables, the postoperative complications and mortality
- side effects of chemotherapy [ Time Frame: during chemotherapy period ]check Anemia, Leukopenia, Neutropenia, Thrombocytopenia, Edema, Fever, Insomnia, Asthenia, Anorexia, Nausea, Vomiting, Constipation, Diarrhea, Hand foot syndrome, Dyspepsia, Creatinine, AST, ALT, Bilirubin, abdominal pain, GI bleeding, diarrhea

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
- A past history of chemotherapy
- tumor with obstruction or perforation
- tumor with distant metastases
- synchronous tumor
- relative or absolute contraindications of chemotherapy
- Recent MI, CVA, nitrate medication
- Severe cardiovascular disease, psychiatric disease
- Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
- Renal dysfunction (Cr ≥2mg/dl)
- The concurrent presence of other severe medical diseases

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460589
Korea, Republic of | |
Kyungpook National University Hospital | |
Daegu, Korea, Republic of, 700-721 | |
Gyu seog Choi | |
Daegu, Korea, Republic of |
Study Chair: | Gyu seog Choi, M.D. | Kyunpook National Univercity Medical Center |
Responsible Party: | Gyu-Seog Choi, Director, Head of colorectal cancer center, Principal Investigator, Professor, Kyungpook National University Hospital |
ClinicalTrials.gov Identifier: | NCT01460589 |
Other Study ID Numbers: |
KNUHCRC004 |
First Posted: | October 27, 2011 Key Record Dates |
Last Update Posted: | June 4, 2020 |
Last Verified: | June 2020 |
colon cancer Chemotherapy adjuvant |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |