deltatrials
Unknown PHASE2 INTERVENTIONAL 2-arm NCT00454519

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

Updated 7 times since 2017 Last updated: Feb 12, 2009 Started: Mar 31, 2007 Primary completion: Dec 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotUnknown Status~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE2

  2. Sep 2024 — Present [monthly]

    Unknown PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE2

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE2

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE2

  2. 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

Sponsor contact:
  • Ikeda Hospital
  • Kishiwada Tokushukai Hospital
  • Kusatsu General Hopital
  • NPO Organization to Support Peritoneal Dissemination Treatment
  • Wuhan University
Data source: Wuhan University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations