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NCT Number: NCT01460589

Early Commencement of Adjuvant Chemotherapy for Colon Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jun Seok Park, Daegu, South Korea

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About this study

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
  • 2,400mg/m2 over 46 hours

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

timing to initiate the adjuvant FOLFOX chemotherapy

Drug

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 names: early commencement of chemotherapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial

Acronym: ECTX

Important dates

Study start
2013
Primary completion
2024
Study completion
2026
First posted
Oct 27, 2011
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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