Intraperitoneal Chemotherapy Versus Triweekly Chemotherapy

NCT ID: NCT05410938

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2023-05-01

Brief Summary

The combination of paclitaxel and carboplatin is the standard first-line chemotherapy for ovarian cancer as recommended by the NCCN Guidelines for Epithelial Ovarian Cancer, and is conventionally given via intravenous route every three weeks. The addition of target therapy (bevacizumab) has shown to improve progression free survival but not overall survival. Several trials have also demonstrated a clinically significant survival advantage associated with intraperitoneal chemotherapy compared to intravenous chemotherapy, and the best outcomes are consistently seen for patients who have no residual disease. This study aims to compare triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.

Conditions

Intraperitoneal Chemotherapy, Bevacizumab, Ovarian Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Intraperitoneal group

The intraperitoneal regimen was given as 135 mg/m2 intravenous paclitaxel over a 3 or 24 hours period on day 1, followed by 75-100 mg/m2 intraperitoneal cisplatin on day 2 and 60 mg/m2 intraperitoneal paclitaxel on day 8. For women with significantly impaired renal function (i.e., estimated glomerular filtration rate\<50 mL/min/1.73 m2), carboplatin (area under the curve \[AUC\]=6) was used instead of cisplatin.

Chemotherapy

Intervention Type: DRUG

Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab

Triweekly group

The triweekly intravenous chemotherapy regimen was given as 175 mg/m2 paclitaxel and carboplatin at a dose calculated to produce an AUC of 6 mg/mL/min on day 1. Bevacizumab was given at a dose of 7.5mg/kg intravenously on day 2 since cycle 2. The treatments were repeated every 3 weeks for 6 cycles. Those women without achievement of complete response after 6 cycles of chemotherapy might be treated with an additional 1-2 cycles of chemotherapy. Bevacizumab was continued for 12 additional cycles or until disease progression, death, unacceptable toxic effects, or patient voluntary withdrawal \[5\].

Chemotherapy

Intervention Type: DRUG

Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab

Interventions

Chemotherapy

Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• women aged 20 and above with FIGO stage II-IV advanced ovarian, fallopian tube or primary peritoneal cancer who received debulking surgery, followed by either triweekly intravenous chemotherapy with bevacizumab or intraperitoneal chemotherapy; women who received neoadjuvant chemotherapy followed by interval debulking surgery were also eligible for participation. Intraperitoneal chemotherapy was defined as having one or more cycles of an intraperitoneal regimen administered.

Exclusion Criteria

• women who quit half-way or received chemotherapy at other site

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sheng-Mou Hsiao

Chief of Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Countries

Taiwan

Other Identifiers

111113-E

Identifier Type: -

Identifier Source: org_study_id