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A prospective, randomized, controlled clinical trial to evaluate the efficacy and safety of interval debulking surgery combined with cisplatin and docetaxel hyperthermic intraperitoneal chemotherapy in patients with advanced ovarian cancer

A prospective, randomized, controlled clinical trial to evaluate the efficacy and safety of interval debulking surgery combined with cisplatin and docetaxel hyperthermic intraperitoneal chemotherapy in patients with advanced ovarian cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043156
Enrollment
Unknown
Registered
2021-02-07
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

ovarian cancer

Interventions

single drug group:Cisplatin intraperitoneal hyperthermia intraperitoneal chemotherapy
Combined drug group:cisplatin and docetaxel hyperthermic intraperitoneal chemotherapy

Sponsors

Beijing Shijitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Aged 18-76 years; 2.Newly diagnosed patients with III and IVA stage epithelial ovarian cancer/fallopian tube cancer / primary peritoneal cancer; 3.Preoperative karnofsky performance status score (KPS)>70 scores; 4.Patients who received 3-4 courses of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 carboplatin AUC 5-6 regimen intravenous chemotherapy), the disease was completely or partially response or stabilized after chemotherapy; 5.Satisfactory cytoreductive surgery (residual tumor 3.5 x 10^9/L, platelet > 100 x 10^9/Lserum creatinine 60ml/minserum bilirubin < upper limit, alanine aminotransferase and aspartate aminotransferase < 3.5 times of upper limit, alkaline phosphatase < 6 times of upper limit.

Exclusion criteria

Exclusion criteria: 1.Preoperative major organ (heart, lung, kidney, liver) dysfunction; 2.Patients with cachexia and unstable vital signs; 3.Breast cancer in the nearly five years; 4.History of malignant tumor, abdominal and pelvic radiotherapy (except thyroid tumor); 5.Known allergic or hypersensitive reactions to cisplatin or other platinum / docetaxel; 6.Anything that would not allow the programme to proceed safely; 7.Pregnancy: pregnancy test positive for women of childbearing age; 8.Patients may be referred to non-participating hospitals during treatment; 9.Poor compliance of patients; 10.Patients with mental illness.

Design outcomes

Primary

MeasureTime frame
recurrence free survival;

Countries

China

Contacts

Public ContactBai Wenpei, Li Yan

Beijing Shijitan Hospital, Capital Medical University

bwp66@163.com+86 10-63926259

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026