Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion
Chinese PLA Generation Hospital
1 other identifier
interventional
70
1 country
1
Brief Summary
Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis. Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedApril 13, 2017
April 1, 2017
3 years
March 16, 2017
April 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peritoneal adhesion ORR (pORR)
Degree of adhesion was measured according to NAIR's criteria by laparoscopy. Grade 0 corresponded to no adhesions, Grade 1 and 2 corresponded to filmy adhesions and grade 3 and 4 to dense adhesions. No adhesions is defined as CR, dense adhesions change to filmy adhesions is defined as PR. The total efficiency ORR was calculated by taking the sum of CR+PR.
3weeks after the last treatment
Secondary Outcomes (5)
Number of Patients with Adverse Events
From first dose up to 1 month after the last treatment
Quality of Life (QoL)
From first dose up to 1 year
Progression free survival (PFS)
Up to 3 years
Overall survival (OS)
Up to 3 years
Objective Response Rate (ORR)
Up to 1 year
Other Outcomes (1)
Expression of VEGF-A in peritoneal cavity
Up to 1 year
Study Arms (2)
Intraperitoneal bevacizumab+ carboplatin
EXPERIMENTALIntraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Intraperitoneal carboplatin
ACTIVE COMPARATORIntraperitoneal administration: intraperitoneal carboplatin every 3 weeks Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Interventions
Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
Eligibility Criteria
You may qualify if:
- Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer.
- Age of 18-70, Karnofsky score higher than 80.
- No severe functional damage of major organ, normal liver and kidney function.
- Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications.
You may not qualify if:
- Complete intestinal obstruction and suitable for surgery.
- Patients known to be allergic to bevacizumab or any of the components of the drug.
- Other ongoing anti-tumor treatment.
- Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure
- Active wound infection and a history of uncontrolled psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100048, China
Related Publications (1)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nan Du, PhD
PLA 304 hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of oncology
Study Record Dates
First Submitted
March 16, 2017
First Posted
March 29, 2017
Study Start
June 1, 2017
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
April 13, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share