Early Commencement of Adjuvant Chemotherapy for Colon Cancer (ECTX)

• ClinicalTrials.gov Identifier: NCT01460589
• Recruitment Status: Active, not recruiting
• First Posted: October 27, 2011
• Last Update Posted: June 4, 2020
• Sponsor: Kyungpook National University Hospital
• Information provided by (Responsible Party): Gyu-Seog Choi, Kyungpook National University Hospital

Tracking Information

• First Submitted Date: October 25, 2011
• First Posted Date: October 27, 2011
• Last Update Posted Date: June 4, 2020
• Study Start Date: November 2011
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2011)

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.

Original Primary Outcome Measures (submitted: October 26, 2011)

3-year 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.

Current Secondary Outcome Measures (submitted: October 26, 2011)

• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Early Commencement of Adjuvant Chemotherapy for Colon Cancer
• Official Title: Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial

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.

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colon Cancer

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

Other Name: early commencement of chemotherapy

Study Arms

• Experimental: early commencement
  Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery
  Intervention: Procedure: timing to initiate the adjuvant chemotherapy
• Active Comparator: conventional commencement
  Individuals who initiate the adjuvant chemotherapy after 14 days after surgery
  Intervention: Procedure: timing to initiate the adjuvant chemotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 23, 2018): 440
• Original Estimated Enrollment (submitted: October 26, 2011): 198
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01460589
• Other Study ID Numbers: KNUHCRC004
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gyu-Seog Choi, Kyungpook National University Hospital
• Study Sponsor: Kyungpook National University Hospital
• Collaborators: Not Provided

Investigators

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

• PRS Account: Kyungpook National University Hospital
• Verification Date: June 2020