Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer

Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer - Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021324

Enrollment

Registered

2016-03-03

Start date

2013-09-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal metastasis from colorectal or appendiceal cancer

Interventions

Intravenous chemotherapy (IV) is given on days 1 and 15 and PTX is given intraperitoneally (IP) at 20 mg/m2 on days 1, 8 and 15. This regimen is repeated every 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven colorectal or appendiceal cancer; peritoneal metastasis; age between 20 and 80 years; Synchronous or metachronous metastasis; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >75,000/mm3); adequate liver function (total serum bilirubin <2.0 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.

Exclusion criteria

Exclusion criteria: Metastasis to distant organ sites (such as liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Overall response rate, 1-year overall survival rate, rate of response in PCI score	—

Countries

Japan

Contacts

Public ContactYoshimasa Gohda

National Center for Global Health and Medicine Department of Surgery

yoshi-gouda@hotmail.co.jp03-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026