Clinical trial • Phase II • Oncology
oxaliplatin for Colon cancer
Phase II trial of oxaliplatin for Colon cancer. open-label, none/not specified-controlled. 60 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colon cancer
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-11-2024
- First CTIS Authorization Date
- 03-12-2024
Trial design
open-label, none/not specified-controlled Phase II trial across 1 site in Denmark.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 60
- Trial Duration For Participant
- 1095
Eligibility
Recruits 60 No vulnerable populations selected (isVulnerablePopulationSelected: false). Standard adult informed consent required; no assent or paediatric consent forms mentioned..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Standard adult informed consent required; no assent or paediatric consent forms mentioned.
Inclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- Performance status 0-1"}
- {"criterion_text":"- Age > 18 years"}
Exclusion criteria
- {"criterion_text":"- Radiologically or clinically proven relapse."}
- {"criterion_text":"- Previous cytoreductive surgery (CRS) with HIPEC"}
- {"criterion_text":"- Other malignant diagnosis within the last 2 years"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Peritoneal recurrence determined by contrast enhanced CT of the thorax and abdomen at 36 months after resection."}
Secondary endpoints
- {"endpoint_text":"- Treatment related toxicity and complication rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Completion rate of two adjuvant PIPAC treatments","definition_or_measurement_approach":""}
- {"endpoint_text":"- 1- and 2-year peritoneal recurrence free survival, based on CT of the thorax and abdomen","definition_or_measurement_approach":"Peritoneal recurrence-free survival at 1 and 2 years assessed by CT of the thorax and abdomen."}
- {"endpoint_text":"- 1-, 2- and 3-year recurrence free survival, based on CT of the thorax and abdomen","definition_or_measurement_approach":"Recurrence-free survival at 1, 2 and 3 years assessed by CT of the thorax and abdomen."}
- {"endpoint_text":"- 1-, 3- and 5-year overall survival rate","definition_or_measurement_approach":"Overall survival at 1, 3 and 5 years."}
- {"endpoint_text":"- The number of conversions from positive to negative peritoneal lavage cytology after one PIPAC procedure","definition_or_measurement_approach":"Change in peritoneal lavage cytology status after one PIPAC procedure (conversion from positive to negative)."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 112
- Consent Approach
- Standard adult informed consent via provided Subject Information Sheet and Informed Consent Form (documents: 'SIS all patients' and 'ICF all patients'). Consent provided by participants themselves. No paediatric assent or paediatric-specific consent documents mentioned; no languages specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Denmark
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 03-12-2024
- Processing Time Days
- 1
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Odense University Hospital
- Department Name
- Department of Surgery
- Contact Person Name
- Martin Graversen
- Contact Person Email
- martin.graversen@rsyd.dk
Sponsor
Primary sponsor
- Full Name
- Odense University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- oxaliplatin
- Modality
- Small molecule
- Routes Of Administration
- INTRAPERITONEAL USE
- Route
- INTRAPERITONEAL USE
- Maximum Dose
- 92 mg
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