EFFIPEC – Efficacy of heated chemotherapy administered into the abdome

Phase 1

Conditions: Colorectal cancer
MedDRA version: 27.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2020-005210-18-SE

Lead Sponsor: ppsala University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

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 <=78 years old.
6. Colorectal cancer with peritoneal metastases +/- liver metastases
7. Concomitant resectable pulmonary metastases
7. All patients deemed eligible for CRS and HIPEC according to clinical routine

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 92

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>Phase III: To study the recurrence-free survival (RFS) of patients within 24 months <br><br><br><br>;Secondary Objective: 1. Overall and recurrence-free survival up to 5 years<br>2. Postoperative complication rates within 30 days<br>3. Quality of life of patients up to 3 years after study treatment <br>;Primary end point(s): Phase I: Maximum tolerated dose of 5-FU 24-hour EPIC. Possible toxicity will be reported as Adverse Events.<br><br>Phase III: Local control rate within 24 months – Defined as peritoneal or liver recurrence. Retroperitoneal llg not included in this definition<br>;Timepoint(s) of evaluation of this end point: Phase I: 30 days post-treatment<br><br>Phase III: within 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are to evaluate the:<br>• Overall survival and RFS up to 5 years through the HIPEC registry<br>• Postoperative complication rates within 30 days <br>• Quality of life of patients up to 3 years after treatment<br><br>;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.<br>Postoperative complication rates are followed for 30 days. <br>QoL questionnaires are filled out at baseline and 12 and 36 months after surgery.