This study has been transitioned to CTIS with ID 2024-517152-34-00 check the CTIS register for the current data. The primary objectives are to explore the overall survival for the addition of intraperitoneal irinotecan (75 mg) to palliative systemic…
ID
Source
Brief title
Condition
- Peritoneal and retroperitoneal conditions
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the anti-tumor activity in patients treated with intraperitoneal
irinotecan (75 mg) and concomitant mFOLFOX4, defined as (1) progression-free
survival (calculated from the interval from the start of trial treatment until
first evidence of intraperitoneal and/or systemic disease progression or last
follow-up); (2) overall survival (calculated from (a) the interval from
diagnosis of peritoneal metastases until death or last follow-up; (b) the
interval from the first day of the first cycle until death or last follow-up).
Secondary outcome
The toxicity profile, patient reported outcomes, costs, tumor response during
trial treatment, and the systemic and intraperitoneal pharmacokinetics of
irinotecan and SN-38.
Background summary
The rationale of the current study is that the addition of intraperitoneal
irinotecan (75 mg) to palliative systemic therapy is feasible and safe, and
might result in an increased overall and progression free survival in patients
with unresectable colorectal peritoneal metastases.
Study objective
This study has been transitioned to CTIS with ID 2024-517152-34-00 check the CTIS register for the current data.
The primary objectives are to explore the overall survival for the addition of
intraperitoneal irinotecan (75 mg) to palliative systemic therapy in patients
with unresectable colorectal peritoneal metastases.
Secondary objectives are to assess the progression-free survival, toxicity
profile, patient reported outcomes, costs, tumor response during trial
treatment, and the systemic and intraperitoneal pharmacokinetics of irinotecan
and SN-38.
Study design
This is a single-arm, open-label, phase II study that is performed in three
Dutch tertiary referral centers for the surgical treatment of colorectal
peritoneal metastases.
Intervention
The addition of intraperitoneal irinotecan (75 mg) to modified FOLFOX4
(mFOLFOX4) + bevacizumab
Study burden and risks
Trial participation involves several potential (small) risks. Firstly, during
the diagnostic laparoscopy a peritoneal port is placed, which is associated
with a small risk of surgical complications. Secondly given the addition of a
cytostatic agent, the most important risk associated with trial participation
involves an increased risk of locoregional or systemic toxicity.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
- Histologically confirmed colorectal cancer;
- Radiologically and clinically or pathologically confirmed unresectable
colorectal peritoneal metastases (e.g. PCI >20, extensive small bowel
involvement, unresectable disease due to anatomical location);
- WHO performance score of 0-1 with a life expectancy of >3 months;
- Aged 18 years or older;
- Written informed consent;
Exclusion criteria
- Presence of extensive systemic metastases that are deemed to be the dominant
factor determining prognosis in terms of life expectancy and performance status
[e.g. no imminent threat of impaired organ functioning due to the presence of
systemic metastases]);
- Prior cytoreductive surgery;
- Prior palliative systemic therapy for colorectal cancer;
- Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the
last 6 months;
- Homozygous UGT1A1*28 genotype;
- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency;
- Microsatellite instable (MSI) primary tumor;
- Any contra-indication for the planned chemotherapy (e.g. active infection,
serious concomitant disease, severe allergy), as determined by the medical
oncologist;
- Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an
absolute neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L,
serum creatinine of >1.5 x ULN, creatinine clearance of <30 ml/min, Bilirubin >
2x ULN and liver transaminases of >5 x ULN;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-517152-34-00 |
| EudraCT | EUCTR2022-002134-14-NL |
| CCMO | NL81672.100.22 |