|
Study period
|
---|
Enrolment/allocation
|
Post-allocation
|
Close-out
|
---|
Outpatient clinics
|
Neoadjuvant treatment
|
CRS-HIPEC
|
Adjuvant treatment
|
3 months after CRS-HIPEC
|
6 months after CRS-HIPEC
|
9 months after CRS-HIPEC
|
Every 6 months
|
5 years after randomisation
|
---|
Enrolment/allocation
|
Eligibility screen
|
X
| | | | | | | | |
Informed consent
|
X
| | | | | | | | |
Allocation
|
X
| | | | | | | | |
Interventions
|
Chemotherapy
| |
X
| |
X
| | | | | |
Bevacizumab
| |
Xa
| | | | | | | |
CRS-HIPEC
| | |
X
| | | | | | |
Thoracoabdominal CT
| |
Xb
| | |
X
| |
X
|
X
|
X
|
Questionnaires
|
X
|
Xc
| | |
X
|
X
|
X
|
X
|
X
|
Translational research: blood
|
X
|
Xd
|
Xe
|
Xd
|
X
| |
X
|
X
|
X
|
Translational research: tissue
| | |
X
| | | | | | |
Assessments
|
Baseline characteristics
|
X
| | | | | | | | |
Feasibility of systemic therapy
| |
X
|
X
|
X
| | | | | |
Safety/toxicity of systemic therapy
| |
X
|
X
|
X
| | | | | |
Radiological response
| |
X
| | | | | | | |
Histopathological response
| | |
X
| | | | | | |
Surgical characteristics
| | |
X
| | | | | | |
Postoperative morbidity
| | |
X
| |
X
| | | | |
Progression-free survival
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
Disease-free survival
| | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
Overall survival
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
Health-related quality of life
|
X
|
X
|
X
| |
X
|
X
|
X
|
X
|
X
|
Costs
|
X
|
X
|
X
| |
X
|
X
|
X
|
X
|
X
|
- CRS-HIPEC cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, CT computed tomographyaAdded to the first three (CAPOX) or four (FOLFOX/FOLFIRI) cycles of neoadjuvant chemotherapy
- bAfter three (CAPOX with bevacizumab) or four (FOLFOX/FOLFIRI with bevacizumab) cycles
- cAfter completion of neoadjuvant systemic therapy, before CRS-HIPEC
- dBetween the first and the second cycle of (neo)adjuvant systemic therapy
- e1 day before CRS-HIPEC and 7 days after CRS-HIPEC