ECTX: Early Commencement of Adjuvant Chemotherapy for Colon Cancer

• Sponsor: Kyungpook National University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01460589
• Collaborator: (none)
• Enrollment: 440
• Locations: 2
• Arms: 2
• Duration (Months): 157
• Patients Per Site: 220
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Procedure: timing to initiate the adjuvant chemotherapy	Phase 3

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2011
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: early commencement Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery	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 Names: early commencement of chemotherapy
Active Comparator: conventional commencement Individuals who initiate the adjuvant chemotherapy after 14 days after surgery	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 Names: early commencement of chemotherapy

Outcome Measures

Primary Outcome Measures

1. 3-year disease free survival rate [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 Outcome Measures

1. short-term cumulative surgery-related complications during chemotherapy [up to 26 weeks after operation]

   A comparison of the postoperative recovery variables, the postoperative complications and mortality

2. side effects of chemotherapy [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook National University Hospital	Daegu		Korea, Republic of	700-721
2	Gyu seog Choi	Daegu		Korea, Republic of

Sponsors and Collaborators

• Kyungpook National University Hospital

Investigators

• Study Chair: Gyu seog Choi, M.D., Kyunpook National Univercity Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 27, 2011
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Gyu-Seog Choi, Director, Head of colorectal cancer center, Principal Investigator, Professor, Kyungpook National University Hospital: colon cancer; Chemotherapy; adjuvant
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of Jun 4, 2020