Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01460589
Other study ID # KNUHCRC004
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT03457454 - Reducing Rural Colon Cancer Disparities
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Completed NCT03390907 - Hybrid APC Assisted EMR for Large Colon Polyps N/A
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT04079478 - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting NCT04057274 - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT05147545 - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects N/A
Recruiting NCT05026268 - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis N/A
Not yet recruiting NCT03277235 - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients N/A
Active, not recruiting NCT02959541 - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer N/A
Active, not recruiting NCT02730702 - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT02526836 - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer Phase 2/Phase 3