Early Commencement of Adjuvant Chemotherapy for Colon Cancer

Colon Cancer Clinical Trial

— ECTX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01460589
• Other study ID #: KNUHCRC004
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Kyungpook National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gyu seog Choi	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate	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.	up to 3 years after operation
Secondary	short-term cumulative surgery-related complications during chemotherapy	A comparison of the postoperative recovery variables, the postoperative complications and mortality	up to 26 weeks after operation
Secondary	side effects of chemotherapy	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	during chemotherapy period