Phase II clinical trial of intraperitoneal paclitaxel combined with conventional chemotherapy for colorectal cancer with peritoneal metastases - iPac-02 trial

Ishihara Soichiro0 个研究点目标入组 40 人开始时间: 2022年6月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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),<=12,000/mm3
•NEU >=1,500/mm3
•Hemoglobin >=8.0g/dL
•Platelet >=100,000/mm3
•AST(GOT) <=100U/L, ALT(GPT) <=100U/L
•T-Bilirubin <=1.5times of standard upper limit value of JCCLS(2019/01/25 revised edition)
•eGFR >=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.

•(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

发起方

Ishihara Soichiro