Clinical trial • Phase II/III • Oncology

BEVACIZUMAB for Peritoneal metastases of colorectal cancer

Phase II/III trial of BEVACIZUMAB for Peritoneal metastases of colorectal cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Peritoneal metastases of colorectal cancer
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
12-11-2024

Trial design

Randomised, open-label, arm a: perioperative systemic therapy (chemo-immunotherapy) plus cytoreductive surgery with hipec. arm b (comparator): upfront cytoreductive surgery with hipec alone (no perioperative systemic therapy).-controlled Phase II/III trial across 9 sites in Belgium, Netherlands.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Perioperative systemic therapy (chemo-immunotherapy) plus cytoreductive surgery with HIPEC. Arm B (comparator): Upfront cytoreductive surgery with HIPEC alone (no perioperative systemic therapy).
Target Sample Size
358

Eligibility

Recruits 358 No vulnerable population selected (isVulnerablePopulationSelected: false). Written informed consent required from adult participants; no assent or parental consent procedures specified in the record..

Pregnancy Exclusion
▪ Pregnancy or lactation.
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Written informed consent required from adult participants; no assent or parental consent procedures specified in the record.

Inclusion criteria

  • {"criterion_text":"- ▪ a World Health Organisation (WHO) performance status of ≤1;\n- ▪ histological or cytological proof of PM of a non-appendiceal colorectal adenocarcinoma with ≤50% of the tumour cells being signet ring cells;\n- ▪ resectable disease determined by a diagnostic laparoscopy/laparotomy in combination with abdominal computed tomography and/or magnetic resonance imaging (MRI); only in patients in whom diagnostic laparoscopy or laparotomy is considered not feasible or valuable (e.g. due to known adhesions impeding adequate PCI scoring), it is also allowed to determine resectability by CT or MRI only (provided that the colorectal PM are histologically or cytologically proven);\n- ▪ no evidence of systemic colorectal metastases within three months prior to enrolment;\n- ▪ no systemic therapy for colorectal cancer within six months prior to enrolment;\n- ▪ no contraindications for CRS-HIPEC;\n- ▪ no previous CRS-HIPEC;\n- ▪ no concurrent malignancies that interfere with the planned study treatment or the prognosis of resected colorectal PM."}

Exclusion criteria

  • {"criterion_text":"- ▪ Inadequate bone marrow, renal, or liver functions (e.g. haemoglobin <6.0 mmol/L, neutrophils <1.5 x 109/L, platelets <100 x 109/L, serum creatinine >1.5 x ULN, creatinine clearance <30 ml/min, bilirubin >2 x ULN, serum liver transaminases >5 x ULN);\n- ▪ Previous intolerance of fluoropyrimidines or both oxaliplatin and irinotecan, to such extent that the oncologist does not consider the patient eligible for systemic therapy;\n- ▪ Serious active infections;\n- ▪ Severe diarrhoea;\n- ▪ Stomatitis or ulceration in the mouth or gastrointestinal tract;\n- ▪ Recent major cardiovascular events;\n- ▪ Unstable or uncompensated respiratory or cardiac disease;\n- ▪ Bleeding diathesis or coagulopathy;\n- ▪ Pregnancy or lactation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To determine the difference between both treatments in terms of overall survival (calculated from the interval from diagnosis of peritoneal metastases until death or last follow-up).","definition_or_measurement_approach":"Overall survival calculated from the interval from diagnosis of peritoneal metastases until death or last follow-up."}

Recruitment

Planned Sample Size
358
Recruitment Window Months
107
Consent Approach
Written informed consent obtained from adult participants. Subject information sheet and informed consent form (L1_SIS and ICF) are provided (documents listed). No assent/parental consent procedures specified; languages of the ICF not specified in the available record.

Geography

Total Number Of Sites
9
Total Number Of Participants
358

Belgium

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
7
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
Surgery
Principal Investigator Name
Kurt van der Speeten
Principal Investigator Email
Kurt.Vanderspeeten@zol.be
Contact Person Name
Kurt van der Speeten
Contact Person Email
Kurt.Vanderspeeten@zol.be

Netherlands

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
6
Number Of Sites
8
Number Of Participants
353

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Surgery
Principal Investigator Name
Patrick Hemmer
Principal Investigator Email
p.h.j.hemmer@umcg.nl
Contact Person Name
Patrick Hemmer
Contact Person Email
p.h.j.hemmer@umcg.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Surgery
Principal Investigator Name
Arend Aalbers
Principal Investigator Email
a.aalbers@nki.nl
Contact Person Name
Arend Aalbers
Contact Person Email
a.aalbers@nki.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Surgery
Principal Investigator Name
Philip de Reuver
Principal Investigator Email
philip.dereuver@radboudumc.nl
Contact Person Name
Philip de Reuver
Contact Person Email
philip.dereuver@radboudumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Surgery
Principal Investigator Name
Wilhelmina van Grevenstein
Principal Investigator Email
w.m.u.vangrevenstein@umcutrecht.nl
Contact Person Name
Wilhelmina van Grevenstein
Site Name
Catharina Ziekenhuis Stichting
Department Name
Surgery
Principal Investigator Name
Ignace De Hingh
Principal Investigator Email
ignace.d.hingh@catharinaziekenhuis.nl
Contact Person Name
Ignace De Hingh
Site Name
Academisch Medisch Centrum
Department Name
Surgery
Principal Investigator Name
Jurriaan Tuynman
Principal Investigator Email
j.tuynman@amsterdamumc.nl
Contact Person Name
Jurriaan Tuynman
Contact Person Email
j.tuynman@amsterdamumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Surgery
Principal Investigator Name
Alexandra Brandt-Kerkhof
Principal Investigator Email
a.brandt-kerkhof@erasmusmc.nl
Contact Person Name
Alexandra Brandt-Kerkhof
Contact Person Email
a.brandt-kerkhof@erasmusmc.nl
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Surgery
Principal Investigator Name
Djamila Boerma
Principal Investigator Email
d.boerma@antoniusziekenhuis.nl
Contact Person Name
Djamila Boerma
Contact Person Email
d.boerma@antoniusziekenhuis.nl

Sponsor

Primary sponsor

Full Name
Catharina Ziekenhuis Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Avastin 25 mg/ml concentrate for solution for infusion.
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number: EU/1/04/300/001)
Maximum Dose
7.5 mg/Kg
Investigational Product Name
Leucovorin-Teva 10 mg/ml Concentrate for Solution for Infusion
Active Substance
FOLINIC ACID
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number: PA 749/1/1)
Maximum Dose
400 mg/m2
Investigational Product Name
Oxaliplatin Eugia 5 mg/ml concentraat voor oplossing voor infusie
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number: BE661053)
Maximum Dose
130 mg/m2
Investigational Product Name
Xeloda 150 mg film-coated tablets
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation number: EU/1/00/163/001)
Maximum Dose
2000 mg/m2
Investigational Product Name
5-Fluorouracil Sandoz 50 mg/ml koncentrátum oldatos infúzióhoz
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number: OGYI-T-7514/01)
Maximum Dose
2800 mg/m2
Investigational Product Name
IRINOTECAN MYLAN GENERICS 20 mg/ml concentrato per soluzione per infusione
Active Substance
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number: 038804098)
Maximum Dose
180 mg/m2
Combination Treatment
Yes

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