Skip to content

A randomized controlled trial for comparing the efficacy of intraperitoneal hyperthermic chemotherapy (HIPEC) with conventional treatment during primary subtractive surgery (PDS) for newly diagnosed ovarian/fallopian tube epithelial cancer in stage II-IV

A randomized controlled trial for comparing the efficacy of intraperitoneal hyperthermic chemotherapy (HIPEC) with conventional treatment during primary subtractive surgery (PDS) for newly diagnosed ovarian/fallopian tube epithelial cancer in stage II-IV

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034192
Enrollment
Unknown
Registered
2020-06-28
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Primary epithelial ovarian/fallopian tube carcinoma

Interventions

Experimental group:Intraperitoneal perfusion chemotherapy was added during PDS
control group:Traditional therapy (PDS+ postoperative adjuvant chemotherapy)

Sponsors

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old; 2. Primary epithelial/fallopian tube carcinoma was pathologically confirmed and stage II~IV was estimated by preoperative imaging; 3. First-time patients who have not received treatment; 4.ECOG score 0-2; 5. The initial probe FOGOTTI score =4.0x10^9/L, hemoglobin >=80g/L, platelet >=80.0x10^9/L (after correction); Serum bilirubin <= ULN, ALT and AST <=ULN; Urea nitrogen (BUN) <=ULN, creatinine (Cr)<=ULN; 7. Obtain written informed consent.

Exclusion criteria

Exclusion criteria: 1. Have a history of other malignant tumor diseases (except thyroid cancer) or have received anti-tumor therapy (including chemotherapy, radiotherapy and surgery); 2. Severe uncontrolled internal and surgical disease or acute infection; 3. Female patients during pregnancy or lactation; 4. Gastrointestinal bleeding, perforation, intestinal obstruction or a history of related diseases; 5. Extensive adhesions in the pelvic cavity and abdomen; 6. Blood images and liver and kidney functions do not meet the requirements of chemotherapy; 7. Failure to complete all treatments and follow-up in our hospital.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
5-year overall survival;2 years overall survival;There was no platinum interval between the two groups. (Platinum resistance/platinum sensitive recurrence);The incidence of grade 3-4 adverse reactions and quality of life were compared between the two groups.;

Countries

China

Contacts

Public ContactFeng Weiwei

Department of Obstetrics and Gynecology, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

wfeng7347@aliyun.com+86 18917763870

Outcome results

None listed

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