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Treatment of advanced ovarian cancer with peritoneal carcinomatosis by laparoscopic delivery of chemotherapeutic agents

Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Suboptimally Cytoreduced Advanced Ovarian Cancer: A Randomized Phase II Trial (PIPAC-OVA)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15843444
Enrollment
120
Registered
2026-03-09
Start date
2020-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suboptimally cytoreduced advanced ovarian cancer Cancer

Interventions

All patients underwent primary cytoreductive surgery, including total hysterectomy, bilateral adnexectomy, and omentectomy, with peritoneal biopsies obtained at laparotomy. No extended surgery (bowel

Sponsors

Moscow Regional Oncological Dispensary
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18 years to 75 years 2. Histologically confirmed advanced epithelial ovarian cancer 3. Presence of peritoneal metastases 4. Suboptimal primary cytoreductive surgery with residual disease greater than 1 cm 5. No extra-peritoneal metastases 6. No malignant pleural effusion 7. No parenchymal organ metastases 8. Eastern Cooperative Oncology Group (ECOG) performance status not equal to 4 9. No synchronous malignancies 10. No receipt of neoadjuvant chemotherapy

Exclusion criteria

Exclusion criteria: 1. Severe concomitant somatic, mental, and other pathology in a stage of exacerbation or decompensation 2. Cachexia with body mass index less than or equal to 16.0 kg/m² 3. Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4 4. Pregnancy and lactation 5. Presence of extra abdominal metastases 6. Presence of a tumour of another localisation, meaning a primary multiple synchronous or metachronous process, except for metachronous neoplasms detected 2 or more years ago and in remission at the time of inclusion 7. Severe adhesions in the abdominal cavity when it is not possible to separate the adhesional conglomerate and achieve complete haemostasis, including cases where an adequate laparoscopic approach cannot be performed 8. Any other clinical condition that, in the opinion of the researcher, may interfere with the safe implementation of the protocol 9. Patient refusal to continue participating in the study at any stage

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival measured using patient records at the data cutoff (15.1.2025);Overall Survival measured using patient records at the data cutoff (15.1.2025)

Countries

Russian Federation

Contacts

Public ContactAlexey Dzasokhov
dzasokhov-pipac@mail.ru+7 9037850613

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026