Overview
Sponsor-declared trial summary
Advanced epithelial ovarian cancer stage III-IV
To investigate whether Ropivacaine 0.2% administered intraperitoneally during surgery and intermittently thereafter for up to 72 h in patients with stage III-IV epithelial ovarian cancer undergoing cytoreductive surgery leads to earlier start of adjuvant chemotherapy.
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Nov 2019 → ongoing
- Decision date (initial)
- 2023-08-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507732-20-00
- EudraCT number
- 2019-003299-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
To investigate whether Ropivacaine 0.2% administered intraperitoneally during surgery and intermittently thereafter for up to 72 h in patients with stage III-IV epithelial ovarian cancer undergoing cytoreductive surgery leads to earlier start of adjuvant chemotherapy.
Secondary objectives 1
- To evaluate postoperative complications and morbidity, quality of recovery and overall survival.
Conditions and MedDRA coding
Advanced epithelial ovarian cancer stage III-IV
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Women > 18 years
- ASA I-III
- Scheduled for upfront cytoreductive surgery for stage III or IV epithelial ovarian cancer
- Signed written informed consent
Exclusion criteria 5
- Contraindication to epidural anesthesia
- Allergy to any component drugs used during epidural or intraperitoneal anesthesia (Ropivacaine, Sufentanil)
- Uncontrolled renal, liver, heart failure or ischemic heart disease
- Speech, language or cognitive difficulties
- Women in whom cytoreductive surgery is not attempted at time of upfront laparotomy due to extent of disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time (days) to start of adjuvant chemotherapy after cytoreductive surgery
Secondary endpoints 1
- Postoperative complications, postoperative morbidity, quality of recovery, cardiac and renal impairment and overall survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB04264MIG · Substance
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- INFUSION
- Route of administration
- INTRAPERITONEAL USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAPERITONEAL USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Sponsor representative
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Sponsor representative
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 220 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2019-11-29 | 2020-09-02 | 2023-12-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | IPLA-OVCA_Study protocol TC | 3.3 |
| Protocol (for publication) | Protocol IPLA-OVCA | 3.3 |
| Protocol (for publication) | Summary of changes protocol IPLA-OVCA v 3_2 vs 3_3 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ropivacain SmPC | 1 |
| Synopsis of the protocol (for publication) | IPLA-OVCA Svensk sammanfattning | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-18 | Sweden | Acceptable 2023-08-28
|
2023-08-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-18 | Sweden | Acceptable 2026-01-23
|
2026-01-23 |