FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01566942

Enrollment

200

Registered

2012-03-30

Start date

2012-06-30

Completion date

2017-06-30

Last updated

2012-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

FOLFIRI, FOLFOX, adjuvant chemotherapy, advanced colorectal cancer

Brief summary

the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.

Interventions

DRUGOxaliplatin

In this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks

DRUGIrinotecan

In this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* histologically confirmed adenocarcinoma in colorectal cancer * clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined * no cancer cells were found in ascites * Eastern Cooperative Oncology Group(ECOG) performance status of 0-2 * male or female, between 18 and 75 years old * adequate hematologic, hepatic and renal functions * without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled * not enrolled into others clinical trial during this study * all patients should sign the informed consent

Exclusion criteria

* can not be tolerated operation * receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study * can not be tolerated the adverse effect of drugs in these regimens * major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery * metastatic disease more than one organ * pregnant or lactating women

Design outcomes

Primary

Measure	Time frame	Description
disease-free survival（DFS）	3-year disease-free survival rate	The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.

Secondary

Measure	Time frame	Description
overall survival(OS)	5-year survival	The 5-year survival rate will be the secondary end point. The investigator will follow up the patients and campare the difference of 5-year-OS between the two groups.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026