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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-free survival(DFS)

Outcome Description:

The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.

Outcome Time Frame:

3-year disease-free survival rate

Safety Issue:

Yes

Principal Investigator

YULONG HE, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

First Affiliated Hospital, Sun Yat-Sen University

Authority:

China: Food and Drug Administration

Study ID:

2011-170

NCT ID:

NCT01566942

Start Date:

June 2012

Completion Date:

June 2017

Related Keywords:

  • Colorectal Cancer
  • FOLFIRI
  • FOLFOX
  • adjuvant chemotherapy
  • advanced colorectal cancer
  • Colorectal Neoplasms

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