Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis (IPHC)
Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 Clinical Trial
Sponsor: Ikeda Hospital
A PHASE2 clinical study on Colorectal Neoplasms and Mesothelioma, this trial is ongoing. The trial is conducted by Ikeda Hospital and has accumulated 7 data snapshots since 2007. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)DISEASE CHARACTERISTICS:
* Histologically confirmed peritoneal carcinomatosis with the following histologies:
* Primary peritoneal mesothelioma
* Adenocarcinoma of gastrointestinal tract origin
* Confined to peritoneal cavity
* Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit
* Must not have failed prior intraperitoneal platinum therapy
* Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy
PATIENT CHARACTERISTICS:
Age:
\- 20 to 70 years old
Performance status:
\- KPS\>50
Life expectancy:
\- More than 8 weeks
Hematopoietic:
* WBC at least 3,500/mm\^3
* Platelet count at least 80,000/mm\^3
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST and ALT no greater than 2 times ULN
* Liver enzymes no greater than 2 times ULN
Renal:
\- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No significant irreversible cardiac ischemia
* No significant changes in ECG recording
Pulmonary:
* FEV\_1 at least 1.2 liters
* Maximum voluntary ventilation at least 50% expected
Other:
* Not pregnant or nursing
* Negative pregnancy test
* No concurrent medical problems that would preclude surgery
DISEASE CHARACTERISTICS:
* Histologically confirmed peritoneal carcinomatosis with the following histologies: * Primary peritoneal mesothelioma * Adenocarcinoma of gastrointestinal tract origin * Confined to peritoneal cavity * Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit * Must not have failed prior intraperitoneal platinum therapy * Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy
PATIENT CHARACTERISTICS:
Age:
\- 20 to 70 years old
Performance status:
\- KPS\>50
Life expectancy:
\- More than 8 weeks
Hematopoietic:
* WBC at least 3,500/mm\^3 * Platelet count at least 80,000/mm\^3
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and ALT no greater than 2 times ULN * Liver enzymes no greater than 2 times ULN
Renal:
\- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No significant irreversible cardiac ischemia * No significant changes in ECG recording
Pulmonary:
* FEV\_1 at least 1.2 liters * Maximum voluntary ventilation at least 50% expected
Other:
* Not pregnant or nursing * Negative pregnancy test * No concurrent medical problems that would preclude surgery
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Unknown PHASE2
-
Sep 2024 — Present [monthly]
Unknown PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE2
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE2
▶ Show 2 earlier versions
-
Feb 2017 — Jun 2018 [monthly]
Unknown Status PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Unknown Status PHASE2
First recorded
Mar 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Ikeda Hospital
- Kishiwada Tokushukai Hospital
- Kusatsu General Hopital
- NPO Organization to Support Peritoneal Dissemination Treatment
- Wuhan University
For direct contact, visit the study record on ClinicalTrials.gov .