Overview
Sponsor-declared trial summary
Colon cancer
As PIPAC seems to have an effect on visible peritoneal metastasis in colon cancer patients, we hypothesize that PIPAC can minimize the risk of PM recurrence in resected high risk colon cancer patients. The main objective of this trial is to test this hypothesis.
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519189-31-00
- EudraCT number
- 2017-002637-37
- ClinicalTrials.gov
- NCT03280511
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
As PIPAC seems to have an effect on visible peritoneal metastasis in colon cancer patients, we hypothesize that PIPAC can minimize the risk of PM recurrence in resected high risk colon cancer patients. The main objective of this trial is to test this hypothesis.
Conditions and MedDRA coding
Colon cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PIPAC OX One armed study. Patients will receive two adjuvant PIPAC treatments with oxaliplatin one month after resection or one month after systemic treatment, if indicated.
|
2 | None |
Regulatory references
- Scientific advice from competent authorities
- Danish Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with high-risk tumors defined as: perforated / pT4NanyM0 (UICC 8th edition) / pTanyNanyM1 with radically resected PM including ovarian metastases
- Performance status 0-1
- Age > 18 years
Exclusion criteria 3
- Radiologically or clinically proven relapse.
- Previous cytoreductive surgery (CRS) with HIPEC
- Other malignant diagnosis within the last 2 years
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The proportion of patients with peritoneal recurrence on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer
Secondary endpoints 6
- Treatment related toxicity and complication rate
- Completion rate of two adjuvant PIPAC treatments
- 1- and 2-year peritoneal recurrence free survival, based on CT of the thorax and abdomen
- 1-, 2- and 3-year recurrence free survival, based on CT of the thorax and abdomen
- 1-, 3- and 5-year overall survival rate
- The number of conversions from positive to negative peritoneal lavage cytology after one PIPAC procedure
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP128961 · ATC
- Active substance
- Oxaliplatin
- Route of administration
- INTRAPERITONEAL USE
- Max daily dose
- 46 mg milligram(s)
- Max total dose
- 92 mg milligram(s)
- Max treatment duration
- 2 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Clinical trial mail address
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Clinical trial mail address
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 60 | 1 |
| 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 |
|---|---|---|---|---|---|
| Denmark | 2024-12-04 | 2024-12-04 | 2024-12-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol 2024-519189-31-00 | 4.1 |
| Recruitment arrangements (for publication) | PLACEHOLDER DOCUMENT Recruitment material patients | 1 |
| Subject information and informed consent form (for publication) | ICF all patients | 4 |
| Subject information and informed consent form (for publication) | SIS all patients | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Oxaliplatin | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis_DAN 2024-519189-31-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-15 | Denmark | Acceptable 2024-11-29
|
2024-12-03 |