FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Irinotecan; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01566942

2011-170

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

FOLFOX

Active Comparator group

Description:

In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.

Treatment:

Drug: Oxaliplatin

FOLFIRI

Experimental group

Description:

in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles

Treatment:

Drug: Irinotecan