Colorectal cancer with peritoneal metastases Colorectal cancer
Conditions
Interventions
mFOLFOX6 + bevacizumab + IP PTX therapy:1 course for 14 days
intraperitoneal paclitaxel on days 1 and 8, Intravenous infusion of bevasizumab (Bmab), levofolinate (l-LV), oxaliplatin (L-OHP), followed
Sponsors
Ishihara Soichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1st registration (1)Histologically confirmed initial or recurrent colorectal adenocarcinoma (exc. appendix cancer and anal canal cancer) (2)The size of peritoneal metastases confirmed by CT scans is 10mm or more (3)Cases without distant metastasis other than peritoneal metastases (4)Cases where chemotherapy for peritoneal metastases has not been performed (5)Adequate function of important organs(within 14 days before registration) White blood cell: >= Standard lower limit value of JCCLS(2019/01/25 revised edition),=1,500/mm3 Hemoglobin >=8.0g/dL Platelet >=100,000/mm3 AST(GOT) =50mL/min/1.73m2 (6)ECOG PS 0-1 (7)The patient survival is expected to be longer than 3 months after registration (8)Aged >=20, <80, at the time of consent (9)Written consent for participation in the study 2nd registration 2nd registration is performed when the peritoneal metastases is pathologically confirmed.After 2nd registration, the implantation of peritoneal access port is performed.
Exclusion criteria
Exclusion criteria: (1)Cases with concurrent active double cancers at 1st registration (2)Cases with a large amount of ascites requiring drainage (3)Cases where peritoneal metastases is resectable (4)Cases less than 180 days from the end of chemotherapy including oxaliplatin to the appearance of peritoneal metastases (5)Contraindicated cases of fluorouracil, Levofolinate, capecitabine, oxaliplatin, bevacizumab or paclitaxel (see latest package insert) (6)Cases with active infections (7)Cases with unhealed wounds (excluding sutures associated with implantable central venous port construction and abdominal port construction) (8)Pregnancy, breast feeding or intention to become pregnant (9)Cases participating other clinical trial (10)Cases with active bleeding, active ulcer lesions and severe gastrointestinal stenosis (but not applicable to cases with stoma) (11)Cases with uncontrolled hypertension (12)Cases with severe diarrhea (13)Cases with serious heart disease (14)Cases with brain tumors (including brain metastases) (15)Cases with arterial thromboembolism (16)Cases of cagulation abnormalities (17)Judged inappropriate for this trial for other reasons (18)Cases of MSI-High
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Overall survival, PCI improvement rate, The rate of negative peritoneal lavage cytology, Safety, Response rate to peritoneal metastases | — |
Contacts
Public ContactKoji Murono
The University of Tokyo Hospital
Outcome results
None listed