UMIN-CTR Clinical Trial

Public title

Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis

Acronym

Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis

Scientific Title

Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis

Scientific Title:Acronym

Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis

Region

Japan

Condition

colorectal cancer with peritoneal metastasis

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of the safety of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Safety

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

20mg/m2 of weekly Intraperitoneal paclitaxel

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

12

Name of lead principal investigator

1st name	Hiroaki
Middle name
Last name	Nozawa

Organization

The University of Tokyo

Division name

Department of Surgical Oncology and Vascular Surgery

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

nozawah-sur@h.u-tokyo.ac.jp

Name of contact person

1st name	Koji
Middle name
Last name	Murono

Organization

The University of Tokyo

Division name

Department of Surgical Oncology and Vascular Surgery

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL

Email

MURONOK-SUR@h.u-tokyo.ac.jp

Institute

The University of Tokyo

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-5800-8743

Email

Irbjimu-tokyo@umin.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

01

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/30386886/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/32495229/

Number of participants that the trial has enrolled

6

Results

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.

Results date posted

2021

Year

01

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Colorectal cancer patients with histologically confirmed peritoneal carcinomatosis were enrolled.

Participant flow

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)

Adverse events

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.

Outcome measures

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.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

06

Month

17

Day

Date of IRB

2016

Year

03

Month

30

Day

Anticipated trial start date

2016

Year

07

Month

01

Day

Last follow-up date

2018

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

06

Month

28

Day

Last modified on

2021

Year

01

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024975