SYF1975778ee7604a75863f2e2343a7d1e5Registry ID: 2024-513376-17-00|RecruitingPhase 2
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interventional
N/A
1 country
1
Primary Objective of this study is to demonstrate the effectiveness of adjuvant PIPAC performed within 4-8 weeks after curative-intent surgery, and followed by adjuvant s-CT, in preventing the onset of PM in high risk colon cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 23, 2024
Actual (reported)The efficacy of adjuvant PIPAC will be assessed by measuring peritoneal metastasis-free survival from the date of primary surgery to the date of MP diagnosis.
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Oxaliplatino Accord 5 mg/ml concentrato per soluzione per infusione
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
LEVOFOLENE 175 mg polvere per soluzione per infusione
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Fluorouracile AHCL 50 mg/ml, Soluzione per iniezione o infusione
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Oxaliplatino Accord 5 mg/ml concentrato per soluzione per infusione
Named ingredient: Oxaliplatin
View registry recordLEVOFOLENE 175 mg polvere per soluzione per infusione
Named ingredient: Levoleucovorin
View registry recordFluorouracile AHCL 50 mg/ml, Soluzione per iniezione o infusione
Named ingredient: Fluorouracil
View registry recordFondazione IRCCS Istituto Nazionale Dei Tumori
Milan, 20133, Italy
Clinical Trials Center
First Submitted
April 23, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Nivolumab Plus FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced Colorectal Cancer RASm/BRAFm Patients
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