A phase II trial of FOLFIRI combined with hyperthermia as second-line therapy of unresectable colon cancer with liver metastases

A phase II trial of FOLFIRI combined with hyperthermia as second-line therapy of unresectable colon cancer with liver metastases - Combination therapy of FOLFIRI and hyperthermia in unresectable colon cancer with liver metastases

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001998

Enrollment

Registered

2009-06-01

Start date

2009-06-01

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

Colon cancer patients with liver metastases who had been treated by FOLFOX as first-line therapy

Interventions

FOLFIRI plus hyperthermia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible criteria in this study are as follows: 1.Histologically confirmed colorectal cancer. 2.Unresectable/reccurent colorectal cancer 3.With liver metastasis 4.With FOLFOX as first-line therapy treated more than 2 courses. 5.More than 2 weeks after the final administration of FOLFOX 6.PS is 0, 1 or 2 7.Over 20 years of age 8.More than 12 weeks of expected survival period 9.With measurable lesion in liver 10.Sufficient functions of main organ a) WBC: >=3,000/mm3 and <12,000/mm3 b) Neutrophyl: >=1,500/ mm3 c) Platelet: >=100,000/ mm3 d) T-Bil.: 1.5 times of normal range in each institute e) GOT, GPT: 2.5 times of normal range in each institute f)sCreatinin: within normal range in each institute 11.Wrtten informed consent

Exclusion criteria

Exclusion criteria: 1.Patients who has received blood transfusion, blood products, and medicine made of blood formation factor within seven days of registration. 2.Medical history of severe hypersensitivity. 3.Massive ascites, pleural or pericardial effusin that required drainage. 4.With active infection. 5.With brain metastasis 6.With active double cancer. 7.Presence of uncontrolled hypertension. 8.Presence of uncontrolled diabetes. 9.Presence of unstable angina, myocardial infarction within three months. 10.Active gastrtrointestinal bleeding. 11.With intestinal paralysis, intestinal obstruction. 12.With diarrhea. 13.Patients receiving Atazanabil. 14.Pregnant or nursing women, men or women who like be pregnant. 15.Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Time to treatment failure, Overall survival, Safety	—

Countries

Japan

Contacts

Public ContactSatoshi Kokura

Graduate School of Medical Science, Kyoto Prefectural University of Medicine Molecular Gastroenterology and Hepatology

s-kokura@koto.kpu-m.ac.jp0752515519

Outcome results

None listed

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