Treatment of advanced ovarian cancer with peritoneal carcinomatosis by laparoscopic delivery of chemotherapeutic agents
| ISRCTN | ISRCTN15843444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15843444 |
| Sponsor | Moscow Regional Oncological Dispensary |
| Funder | Moscow Regional Oncological Dispensary |
- Submission date
- 09/03/2026
- Registration date
- 09/03/2026
- Last edited
- 09/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alexey Dzasokhov
Principal investigator, Scientific, Public
Principal investigator, Scientific, Public
Moscow Regional Oncological Dispensary
6 Karbysheva Str.
Balashikha
143900
Russian Federation
 ORCID ID |
0000-0003-4977-3533 |
|---|---|
| Phone | +7 9037850613 |
| dzasokhov-pipac@mail.ru |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Suboptimally Cytoreduced Advanced Ovarian Cancer: A Randomized Phase II Trial (PIPAC-OVA) | |
| Study objectives | ||
| Ethics approval(s) |
Submitted 09/04/2021, Ethics Committee and the Scientific Council of the P.A. Hertsen Moscow Cancer Research Institute (125284, Moscow, 2nd Botkinsky proezd, 3, Moscow, 125284, Russian Federation; +7 495 150-11-22; mnioi@mail.ru), ref: protocol #661 | |
| Health condition(s) or problem(s) studied | Suboptimally cytoreduced advanced ovarian cancer | |
| Intervention | All patients underwent primary cytoreductive surgery, including total hysterectomy, bilateral adnexectomy, and omentectomy, with peritoneal biopsies obtained at laparotomy. No extended surgery (bowel resection, peritonectomy, etc.) was performed. Patients were randomly assigned (1:1) intraoperatively to receive either standard systemic chemotherapy alone or systemic chemotherapy plus adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC). Patient randomization was carried out using the website random.org. Systemic chemotherapy consisted of paclitaxel (175 mg/m²) and carboplatin (AUC 5–7) administered every 3 weeks for six cycles. In the experimental arm, patients additionally received three PIPAC procedures with cisplatin (10.5 mg/m²) and doxorubicin (2.1 mg/m²), administered immediately after cytoreduction and before the third and fifth chemotherapy cycles. The primary endpoint was progression-free survival (PFS), defined as the time from cytoreductive surgery to disease progression or death from any cause. Secondary end points included overall survival (OS), CA-125 response, local peritoneal disease control, and safety. Radiologic assessments with CT or MRI and serum CA-125 measurements were performed at baseline, during treatment, and at regular intervals during follow-up. In the PIPAC group, protocol-mandated diagnostic laparoscopy at 6 months included reassessment of the peritoneal cancer index (PCI) and repeat peritoneal biopsy for histologic evaluation. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. The primary efficacy analyses were conducted according to the modified intention-to-treat (mITT) principle, including all randomized patients in their assigned groups (n=186), excluding 4 patients with a diagnosis other than EOC on definitive histology. Patients who withdrew consent were censored on the date of withdrawal (for time-to-event endpoints) and contributed follow-up time up to that date. Safety analyses were performed in the as-treated population, defined as all patients who received at least one component of the allocated treatment (n=169). | |
| Intervention type | Procedure/Surgery | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 15/01/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Target sample size at registration | 120 |
| Total final enrolment | 190 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2020 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 09/04/2021 | 09/03/2026 | No | No |
Additional files
- 49165 AD_PIPAC-OVA_Stude Protocol_V 1.0 09Apr2021.pdf
- Protocol file
Editorial Notes
09/03/2026: Trial's existence confirmed by Ethics Committee and the Scientific Council of the P.A. Hertsen Moscow Cancer Research Institute.
