colorectal cancer Oigometastases ctDNA mFOLFOXIRI
Conditions
Interventions
[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 p
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
C509829
FOLFOXIRI
Sponsors
Kataoka Kozo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment compliance (at 8 cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: cfDNA/ctDNA positive rate DFS/OS in cfDNA/ctDNA positive and negative groups Secondary endpoints safety, DFS, OS, Cleared ctDNA rate | — |
Contacts
Public ContactMai Fujimori
Hyogo Medical University Hospital
Outcome results
None listed