Clinical trial · Interventional
IPHC in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Surgery and Intraperitoneal Hyperthermic Chemotherapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer .
- 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)
In patient with a platinum sensitive ovarian cancer recurrence is demonstrated that the re-challenge with a compound of platinum-based, or a treatment with carboplatin in combination with paclitaxel , determines a rate of clinical response similar to the primary treatment, which is all the more important as the longer the time to progression from the primary therapy.In the clinical setting there are many studies that have shown activity of oxaliplatin and docetaxel in patients with advanced ovarian cancer. Two recent studies have shown clinical efficacy of the combination carboplatin / docetaxel in the first line oxaliplatin / paclitaxel to recurrence of disease, confirming the data already obtained from studies of activity in a single agent.In surgery it has been demonstrated in a meta-analysis including approximately 7000 patients in advanced stages of disease, that the extent of cytoreduction is the most powerful determinant of survival.The role of secondary surgical cytoreduction in case of recurrent disease has yet to be determined because of the lack of prospective randomized clinical studies that may highlight the superiority of such aggressive treatment.The combination of aggressive cytoreductive surgery and hyperthermic intraperitoneal intraoperative chemotherapy (CHIP) used in recent clinical studies showed a prolonged time to progression and disease-free survival in patients with ovarian cancer. However, these studies were conducted on groups of patients with very different among themselves and with other drugs, it is difficult to draw definitive conclusions.Given the activities of oxaliplatin and docetaxel and their non-cross-resistance we designed a Phase 2 clinical trial on treatment of patients with recurrent ovarian cancer, platinum-sensitive, treated with surgical cytoreduction with hyperthermic oxaliplatin-based intraoperative intraperitoneal chemotherapy and following consolidation treatment with oxaliplatin and docetaxel systemically every 21 days.
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 |
|---|---|---|---|
| Ovarian Epithelial Cancer Recurrent | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIPEC
- description
- Surgery plus HIPEC
- interventionNames
- Procedure: HIPEC
Primary outcomes (1)
- measure
- Progression free survival,Overall survival, post operative complications(bowel obstruction,intestinal perforation, hemathologic toxicity (granulocytopenia,thrombocytopenia,anemia),neuropathy.
- timeFrame
- 6-32 months
- description
- Efficacy and tolerability of the treatment with intraoperative intraperitoneal hyperthermic chemotherapy with oxaliplatin after optimal debulking surgery in patients with platinum-sensitive recurrent ovarian cancer followed by systemic chemotherapy with docetaxel 75mg / m g1 and oxaliplatin 100 mg / m² every 21 days x g1 for six consecutive cycles.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 and under 70 years * Patients affected by a first recurrence of ovarian cancer with measurable lesions or not, but evaluable (upwards of Ca125 for 2 consecutive assessments). * ECOG-performance status ≤ 2 * Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation * Evidence of tumor recurrence diagnosed after 6 months from primary treatment * Previous-based chemotherapy of carboplatin and taxanes * Positive Peritoneal Washing in the presence of other abdominal disease surgically resectable * Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count \> 1500/mm3, platelets \> 150,000/μl, creatinine clearance \> 60 mL/min according to Cockroft formula) * Patient-compliant and psychologically able to follow the trial procedures Exclusion Criteria: * Non-epithelial ovarian cancer or borderline ovarian tumor * Pregnancy or breastfeeding * Patients affected by major depressive disorder even in treatment or minor mood disorders * Patients with severe impairment of respiratory, hepatic or renal function * Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease * Patients with active infection or other neoplastic disease in progress * Patients with bowel obstruction * Inadequate bone marrow, liver, kidney function * No clear-peritoneal disease at surgical exploration * Patients with ascites \> 500 ml (the TAC) * Patients on maintenance therapy with Antiangiogenic drugs * Patients with secondary or tertiary recurrence, or already submitted to HIPEC * Patients who have already made the second or third line chemotherapy.
References
Publications (1)
- DERIVEDFagotti A, Petrillo M, Costantini B, Fanfani F, Gallotta V, Chiantera V, Turco LC, Bottoni C, Scambia G. Minimally invasive secondary cytoreduction plus HIPEC for recurrent ovarian cancer: a case series. Gynecol Oncol. 2014 Feb;132(2):303-6. doi: 10.1016/j.ygyno.2013.12.028. Epub 2013 Dec 27. PMID 24378877