Clinical trial · Interventional
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma : Randomized Clinical Trial.
- 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)
The purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Carcinomatosis From Ovarian Cancer | Fallopian Tube Neoplasm | PROBABILISTIC | 0.70 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytoreduction | Procedure | — | UNRESOLVED |
| Hipec with Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Comparator
- description
- Comparator
- interventionNames
- Procedure: Cytoreduction
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Experimental
- interventionNames
- Procedure: Cytoreduction
- Drug: Hipec with Cisplatin
Primary outcomes (1)
- measure
- disease-free survival period
- timeFrame
- Every 3 months up to 30 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma. * Residual tumor \< 2.5 mm after completion of cytoreductive surgery. * Aged \< 75 years. * Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group). * Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3. * Adequate renal function with creatinine ? 1.5 mg/ dl. * Adequate liver function with bilirubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L. * Optimal cardiopulmonary function. * In recurrences, disease-free interval \> 6 months. * Voluntary and signed written informed consent. Exclusion Criteria: * Extraperitoneal tumor disease. * Suboptimal debulking (residual tumor \> 2.5 mm). * Previous history of other malignancies (excluding skin) * Intestinal obstruction at the time of evaluation. * Renal failure. * Heart failure. * Uncontrolled infection. * Pregnant or lactating patients. * In recurrences, disease-free interval \< 6 months.
References
Publications (1)
- DERIVEDCascales Campos PA, Gonzalez-Gil A, Gomez-Ruiz AJ, Gil-Gomez E, Alconchel-Gago F, Navarro-Barrios A, Martinez-Garcia J, Alonso-Romero JL, Nieto A, Barcelo-Valcarcel F, Gil-Martinez J. Risk factors and management of incisional hernia after cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal surface malignancies. Hernia. 2020 Apr;24(2):257-263. doi: 10.1007/s10029-019-01962-4. Epub 2019 May 8. PMID 31069579