Clinical trial NCT01460589: Early Commencement of Adjuvant Chemotherapy for Colon Cancer
Official title: Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colon Cancer
Keywords: colon cancer
Chemotherapy
adjuvant
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2011-10-27
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: up to 3 years after operation
Secondary outcomes:
measure: short-term cumulative surgery-related complications during chemotherapy
timeFrame: up to 26 weeks after operation
measure: side effects of chemotherapy
timeFrame: during chemotherapy period
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Gyu seog Choi
Study officials:
affiliation: Kyunpook National Univercity Medical Center
name: Gyu seog Choi, M.D.
role: STUDY_CHAIR
References: