Clinical trial · Interventional
Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to slow accrual
Summary
Brief summary (as posted)
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells. PURPOSE: This phase II trial is studying how well mitomycin works when given as a hyperthermic peritoneal perfusion in treating patients with malignant ascites.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with Malignant Ascites
- description
- Patients meeting protocol criteria enrolled with malignant ascites.
- interventionNames
- Drug: mitomycin C
Primary outcomes (1)
- measure
- Prevention of malignant recurrence
- timeFrame
- Week 4 after treatment
Secondary outcomes (2)
- measure
- Quality of life after treatment
- timeFrame
- Week 4 after treatment
- measure
- Comparison of serum vascular endothelial growth factor (VEGF) levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of peritoneal metastases and malignant ascites by physical examination, ultrasound, or CT scan * Not eligible for cytoreductive surgery based on any of the following criteria: * Metastases outside peritoneal cavity * Poor performance status * Unresectable peritoneal disease * Must have undergone at least 1 prior paracentesis procedure * No ascites caused by any of the following conditions: * Cardiac failure * Nephrotic syndrome * Pancreatic ascites * Chylous ascites * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 70,000/mm\^3 * Bilirubin ≤ 2.0 mg/dL * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test Exclusion Criteria: * Prior peritoneal chemotherapy * Dense intraabdominal adhesions limiting laparoscopy
References
Publications (0)
Data not yet available