Clinical trial · Interventional
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Using Cisplatin, Mitomycin, and Adriamycin in Peritoneal Surface Malignancies Also Known as Hyperthermic Intraperitoneal Chemotherapy.
NCT02349958CI-TRIAL-00038147HIPEC/IPHCunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine treatment response to surgical debulking and intra-operative Intraperitoneal Hyperthermic Chemotherapy (IPHC) in patients with the following malignancies: Gynecologic cancers (ovarian, primary peritoneal or fallopian tube, and uterine/cervical cancers). Mesotheliomas. GI cancers (Gallbladder, liver, small intestine, pancreas, stomach, colon, appendix). To monitor the toxicities and complications of this treatment regimen. To measure treatment related QOL changes after IPHC.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Cancers | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Mesotheliomas | Malignant Mesothelioma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC: CDDP 75 mg/m2 @T0 | Device | — | UNRESOLVED |
| HIPEC: CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0 | Device | — | UNRESOLVED |
| HIPEC: MMC 30mg @ T0, 10mg @ T45min | Device | — | UNRESOLVED |
| HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Ovarian peritoneal
- description
- CDDP Cisplatin 75 mg/m2 @T0 Ovarian peritoneal fallopian tube Uterine
- interventionNames
- Device: HIPEC: CDDP 75 mg/m2 @T0
- type
- OTHER
- label
- Appendix Psuedomyxoma
- description
- MMC Mitomycin 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0 Appendix Psuedomyxoma colorectal small bowel
- interventionNames
- Device: HIPEC: MMC 30mg @ T0, 10mg @ T45min
- type
- OTHER
- label
- Gastric and Pancreato-biliary
- description
- MMC Mitomycin + CDDP Cisplatin 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
PATIENT ELIGIBILITY Presumptive clinical diagnosis of a peritoneal surface cancer (PSC) prior to surgery, with no metastases outside of the abdomen. Patients must have a performance status of 0, 1, or 2. Patients must have adequate: Bone marrow function: absolute neutrophil count more than or equal to 1500 and platelet count more than or equal to 100,000 Renal function: creatinine less than or equal to 1.5 mg/dl Hepatic function: bilirubin less than or equal 1.5times upper limit of normal, SGOT and alkaline phosphatase less than or equal 2.5 times upper limit of normal range Patients must have signed an informed consent. Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception. Patients are at least 18 years of age, and under 75 years of age. At the time of surgery, operative assessment and frozen section diagnosis of one of the following: Primary ovarian cancer (POC) with Stage IC or greater stage Recurrent or persistent ovarian cancer (ROC) Ovarian cancer patients who desire Consolidation Chemotherapy (CC). These patients would ordinarily choose to have 12 cycles of Taxol given after standard first-line surgery and chemotherapy, and instead choose one course of IPHC as their CC. Uterine malignancy of the corpus, or cervix with primary tumor Stage IIIA or greater, or recurrent tumor confined to the abdomen. Metastatic mesothelioma or sarcoma confined to the abdomen. Recurrent or primary gastrointestinal cancer, with regional spread confined to the peritoneal cavity PATIENT INELIGIBILITY Patients with known extra-abdominal disease, or unresected bulky abdominal retroperitoneal lymph nodes. Patients with any evidence of another malignancy within the last five years (except non-melanoma skin cancer) Patients with a known sensitivity to cisplatin, Mitomycin C, or Adriamycin. Patients with significant co-morbid medical conditions that would prevent the patient from completing treatment on this protocol, per Investigator discretion. Patients desiring future fertility.
References
Publications (0)
Data not yet available
No reference posted for this study.