Colorectal Cancer
Conditions
Keywords
Organoid, Drug Test
Brief summary
The purpose of this study is to investigate whether chemotherapy guided by patient-derived tumor organoid drug test can improve the outcomes of stage IV colorectal cancer.
Detailed description
Fluorouracil-based chemotherapy is the standard treatment for stage IV colorectal cancer patients. However, the effects of chemotherapy remains limited. Patient-derived tumor organoids are increasingly used as tools for drug test and predicting drug response in the clinic, and have been showed to faithfully predict clinical outcomes of patients with CRC. A prospective clinical trial is needed to validate whether the in vitro sensitivity to chemotherapy regimens in organoids drug test is associated with a longer PFS in stage IV colorectal cancer.
Interventions
DRUGFOLFOX , FOLFIRI or FOLFOXIRI regimens
FOLFOX (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle FOLFIRI (irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle FOLFOXIRI (irinotecan 150mg/m2, and folinic acid 400mg/m2, oxaliplatin 85 mg/m2, 5-fluorouracil 3200 mg/m2 48-h continuous infusion) for 6 cycle
DRUGFOLFOX or CapeOX regimens
FOLFOX (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle CaoeOX (Oxaliplatin 130 mg/m2 intravenous infusion on day 1,Capecitabine 1000 mg/m2 twice daily PO for 14 days)
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Sun Yat-sen University
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 70 * Histological confirmed colorectal cancer * Stage IV * American Society of Anesthesiologists (ASA) score I\ III * No contraindication for chemotherapy * No evidence of other malignant tumor
Exclusion criteria
* Refusing chemotherapy * Pregnant or breast-feeding women * Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Progression-free survival | up to 1 years | the time from randomization to relapse or death, whichever occurred first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 5 years | the time from randomization to death from any cause |
Countries
China
Contacts
Primary ContactJun Yan, M.D., Ph.D
Outcome results
None listed