mFOLFOXIRI for oligometastatic CRC

JRCT ID: jRCTs051200026

Registered date:08/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 17/07/2020
• Target sample size: 85
• Study type: Interventional

Intervention(s)

[First step eligible patients]
1)Surgery based on the principle of each site. Second step surgery for primary tumor and metastatic tumor(s) are alllowed
2)Blood exam for cfDNA/ctDNA analysis at four points; before surgery, 28days after surgery, 4 months after surgery and 7 months after surgery
[Second step eligible patients]
mFOLFOXIRI therapy (8 cycles maximum)
mFOLFOXIRI administered every 2 weeks for 8 cycles maximum
1. 90min infusion of irinotecan 150 mg/m2 (day1)
2. 2-hour infusion of oxaliplatin 85 mg/m2 and levofolinate 200 mg/m2(day1)
3. 48-hour continuous infusion (day2-3)

[Maintenance therapy (4 cycles)]
1) 2-hour infusion of levofolinate 200 mg/m2
2) 48-hour continuous infusion of fluorouracil 2400 mg/m2

Outcome(s)

• Primary Outcome: Treatment compliance (at 8 cycles)

Secondary Outcome

Key secondary endpoint:
cfDNA/ctDNA positive rate
DFS/OS in cfDNA/ctDNA positive and negative groups
Secondary endpoints
safety, DFS, OS, Cleared ctDNA rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

[Inclusion criteria for first step]
1)Histologically proven for colorectal cancer
2)surgical resection is planned for both primar tumor and metastatic site(s) (liver, lung, ovary and peritoneum)
3)Metastatic site(s) planned for resection was diagnosed by CT scan and no other metastases
4)No previous history of chemotherapy and radiotherapy
5)aged between 20 and 75 years old
6) ECOG PS0-1 (PS0 for patients aged 70 or older
7)Consent for blood exam for cfDNA/ctDNA analysis
8)Sufficient blood and organ function
9)Written informed consent
[Inclusion crieria for second step]
1)Between 28 and 70 days after resection of metastatic site(s)
2)Ro surgical resection achieved for both primary and metastatic site(s)
3)Sufficient blood and organ function
4)no recurrence or metastases in CT scan
5)wild-type (ie, *1/*1) or single heterozygous (ie, *1/*6 or *1/*28) UGT1A1 genotype

Exclude criteria

1)Active other malignancies
2)Pregnancy, possible pregnancy or breastfeeding
3)Severe pulmonary fibrosis or emphysema
4)Psychiatric disease
5)Patients requiring systemic steroid medication
6)Poorly controlled diabetes mellitus
7) Grade 2 or greater diarrhea or sensory neuropathy
8)Poorly controlled hypertension
9)History of severe heart disease, heart failure, unstable angina within 6 months or angina attack with 6 months

Related Information

• Primary Sponsor: Kataoka Kozo
• Source(s) of Monetary Support: Japan Society of Clinical Oncology