Unique ID issued by UMIN | UMIN000022924 |
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Receipt number | R000024975 |
Scientific Title | Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis |
Date of disclosure of the study information | 2016/07/01 |
Last modified on | 2021/01/19 11:09:10 |
Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Japan |
colorectal cancer with peritoneal metastasis
Gastrointestinal surgery |
Malignancy
NO
Evaluation of the safety of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX
Safety
Exploratory
Pragmatic
Phase I
Safety
One year survival rate, progression free survival, response rate, the rate of improvement of peritoneal cancer index, the rate of negative conversion of the cytology of peritoneal lavage
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
20mg/m2 of weekly Intraperitoneal paclitaxel
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) The cases of primary or recurrent colorectal cancer which are histologically confirmed as adenocarcinoma. (The cases of appendiceal carcinoma and anal canal cancer are excluded.)
2) Peritoneal carcinomatosis is detected or suspected.
3) The cases without uncontrollable distant metastases.
4) The cases within 2 months from the beginning of surgery or chemotherapy for peritoneal carcinomatosis.
5) The cases which meet criteria as follows:
1. The number of white blood cells:
More than lower limit of standard value and less than 12,000/mm3
2. The number of neutrophil:
More than 1,500/mm3
3. The amount of hemoglobin:
More than 8.0 g/dl
4. The number of platelet:
More than 100,000/mm3
5. AST/ALT:
Less than 100 U/L
6. Total bilirubin:
Less than 1.5 times as much as upper limit of standard value.
7. eGFR:
More than eGFR: 60 mL/min/1.73m2
6) Performance Status (ECOG scale): 0-1
7) Informed consent is obtained.
1) The patients who have another cancer in the time of entry.
2) The patients who have large amount of ascites which requires drainage more than three times per week.
3) Postoperative chemotherapy including oxaliplatin was performed within 1 year.
4) The cases with contraindication of fluorouracil, levofolinate calcium, capecitabine, oxaliplatin, bevacizumab, or paclitaxel.
5) The patients with brain tumors or brain metastases.
6) The patients with infectious diseases.
7) The patients with thrombotic diseases or embolic diseases within one year.
8) The patients requiring anticoagulant drug.
9) PT-INR>1.5 or tendency to bleed.
10) The patients who are pregnant.
11) Attending doctor decided the patients are unsuitable for this study.
12
1st name | Hiroaki |
Middle name | |
Last name | Nozawa |
The University of Tokyo
Department of Surgical Oncology and Vascular Surgery
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
nozawah-sur@h.u-tokyo.ac.jp
1st name | Koji |
Middle name | |
Last name | Murono |
The University of Tokyo
Department of Surgical Oncology and Vascular Surgery
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
MURONOK-SUR@h.u-tokyo.ac.jp
The University of Tokyo
None
Self funding
The University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-5800-8743
Irbjimu-tokyo@umin.ac.jp
NO
2016 | Year | 07 | Month | 01 | Day |
https://pubmed.ncbi.nlm.nih.gov/30386886/
Published
https://pubmed.ncbi.nlm.nih.gov/32495229/
6
The adverse events of mFOLFOX6-bevacizumab or CapeOX-bevacizumab in combination with ip PTX were considered similar to those described in previous studies of oxaliplatin-based treatment alone.
The response rate was 25%. PCI score improved in 50% of the cases. Peritoneal lavage cytology turned negative during chemotherapy in all patients. One-year survival rate was 100%, progression-free survival was 8.8 months, and median survival time was 29.3 months.
2021 | Year | 01 | Month | 19 | Day |
Colorectal cancer patients with histologically confirmed peritoneal carcinomatosis were enrolled.
Written informed consent was obtained from all patients. This study was approved by the ethics committee of the University of Tokyo (P2015038-11X).
Patients underwent implantation of the peritoneal access port. The catheter was laparoscopically inserted into the pouch of Douglas.
The patients could select the chemotherapeutic regimen, 5-fluorouracil, folinic acid, oxaliplatin, and bevacizumab (mFOLFOX6-bevacizumab) or capecitabine, oxaliplatin, and bevacizumab (CapeOX-bevacizumab)
Overall, grade 3 adverse events, such as leukopenia and neutropenia, were observed in 2 of 3 patients (66.7%) for each chemotherapeutic regimen, but no grade 4 adverse events were observed.
Primary endpoint was the safety of the combination chemotherapy.
Secondary endpoint was response rate, progression-free survival, 1-year survival, frequency of improvement in peritoneal cancer index (PCI), and cytology in peritoneal lavage.
Completed
2016 | Year | 06 | Month | 17 | Day |
2016 | Year | 03 | Month | 30 | Day |
2016 | Year | 07 | Month | 01 | Day |
2018 | Year | 10 | Month | 01 | Day |
2016 | Year | 06 | Month | 28 | Day |
2021 | Year | 01 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024975
Research Plan | |
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Registered date | File name |
2021/01/19 | ●実施計画書第1相 第5版.docx |
Research case data specifications | |
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Registered date | File name |
2021/01/19 | データ仕様書.docx |
Research case data | |
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Registered date | File name |
2021/01/19 | ●ipパクリ (1).xlsx |