Early Commencement of Adjuvant Chemotherapy for Colon Cancer - Full Text View

Purpose

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	Intervention	Phase
Colon Cancer	Procedure: timing to initiate the adjuvant chemotherapy	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Kyungpook National University:

Primary Outcome Measures:

3-year disease free survival rate [ Time Frame: up to 3 years after operation ] [ Designated as safety issue: No ]
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:

short-term cumulative surgery-related complications during chemotherapy [ Time Frame: up to 26 weeks after operation ] [ Designated as safety issue: Yes ]
A comparison of the postoperative recovery variables, the postoperative complications and mortality
side effects of chemotherapy [ Time Frame: during chemotherapy period ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	198
Study Start Date:	November 2011
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: early commencement of chemotherapy

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460589

Locations

Korea, Republic of
Gyu seog Choi
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721

Sponsors and Collaborators

Kyungpook National University

Investigators

Study Chair:

Gyu seog Choi, M.D.

Kyunpook National Univercity Medical Center

More Information

No publications provided

Responsible Party:	Gyu-Seog Choi, Director, Head of colorectal cancer center, Principal Investigator, Professor, Kyungpook National University
ClinicalTrials.gov Identifier:	NCT01460589 History of Changes
Other Study ID Numbers:	KNUHCRC004
Study First Received:	October 25, 2011
Last Updated:	December 5, 2011
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Kyungpook National University:

colon cancer
Chemotherapy
adjuvant

Additional relevant MeSH terms:

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

Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013

Early Commencement of Adjuvant Chemotherapy for Colon Cancer (ECTX)