Colorectal cancer MedDRA version: 27.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Fluorouracil Accord
Product Name: 5-fluorouracil
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracil
CAS Number: 51-21-8
Other descriptive name: FLUOROURACIL
Trad
Sponsors
Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent prior to any study specific procedures. 2. ECOG Performance Status Score 0,1 or 2, alternatively Karnofsky 60-100 3. Adequate kidney, liver, bone marrow function according to laboratory tests. 4. For females of childbearing potential, a negative pregnancy test must be documented. 5. = 18 years old and =65 years) yes F.1.3.1 Number of subjects for this age range 92
Exclusion criteria
Exclusion criteria: 1. Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil 2. Unable to tolerate intensified HIPEC treatment due to comorbidity 3. Metastasis other than peritoneum or liver or lung (ie paraaortal lymph node or bone metastases) 4. Previous CRS or HIPEC 5. Pregnant or lactating (nursing) women 6. Active infections requiring antibiotics 7. Active liver disease with positive serology for active hepatitis B, C, or known HIV 8. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment 9. Incomplete cytoreduction defined as completeness of cytoreduction score 2-3 10. Histopathology of other origin than colorectal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: To determine the maximum tolerated dose of 5-Fluorouracil 24-hour EPIC, in combination with intensified oxaliplatin/irinotecan HIPEC, for treatment of colorectal cancer. Phase III: To study the recurrence-free survival (RFS) of patients within 24 months ;Secondary Objective: 1. Overall and recurrence-free survival up to 5 years 2. Postoperative complication rates within 30 days 3. Quality of life of patients up to 3 years after study treatment ;Primary end point(s): Phase I: Maximum tolerated dose of 5-FU 24-hour EPIC. Possible toxicity will be reported as Adverse Events. Phase III: Local control rate within 24 months – Defined as peritoneal or liver recurrence. Retroperitoneal llg not included in this definition ;Timepoint(s) of evaluation of this end point: Phase I: 30 days post-treatment Phase III: within 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are to evaluate the: • Overall survival and RFS up to 5 years through the HIPEC registry • Postoperative complication rates within 30 days • Quality of life of patients up to 3 years after treatment ;Timepoint(s) of evaluation of this end point: RFS is assessed 1 year, 3 years and 5 years after treatment. Overall survival is assessed 5 years after treatment. Postoperative complication rates are followed for 30 days. QoL questionnaires are filled out at baseline and 12 and 36 months after surgery. | — |
Countries
Sweden
Contacts
Public ContactPeter Cashin
Uppsala University
Outcome results
None listed