Efficacy of Hyperthermic Intraperitoneal Chemotherapy

Colorectal Cancer Clinical Trial

— EFFIPEC  

Official title:

EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy, Single-arm Phase I Study, Followed by an Open-label, Randomized, Controlled Registry-based Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861558
• Other study ID #: EFFIPEC01
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2021
• Est. completion date: December 2029

Study information

• Verified date: December 2023
• Source: Uppsala University
• Contact: Peter Cashin, MD, PhD
• Phone: +46 (0)18 6174304
• Email: peter.cashin[@]surgsci.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A dose titration study and a combined superiority registry-based open-label randomized control trial is planned to answer the trial objectives. The study will be registry-based to allow simpler and more comprehensive follow-up. Patients with colorectal cancer will be treated with cytoreductive surgery (CRS) together with either standard oxaliplatin HIPEC (the control for the efficacy study) or oxaliplatin/irinotecan HIPEC in combination with 5-FU 24-hour EPIC. The 5-FU will be administered postoperatively when the abdomen is completely sutured. The drug is divided equally into 2 injections of 200 ml each and injected through two abdominal drains that are clamped for 16 hours.

For dose escalation, the titration groups (á 3 or 6 patients) are followed for 30 days postoperatively after which the Data Monitoring Committee (DMC) will determine whether or not to increase the 5-FU dose for the following group of patients.

To study efficacy, randomization is performed intraoperatively. The patient is followed up postoperatively for a total of 3 years for the secondary endpoints which may be extended by the study committee to 5 years. Since the trial is registry based, the long-term follow-up does not require separate eCRF evaluations. These evaluations can be automatically retrieved from the registry - both recurrence data, quality of life, and morbidity data. Some specific eCRF evaluations will be integrated as a separate study part of the HIPEC registry, such as inclusion/exclusion criteria and adverse event reporting (including SUSAR reporting).

Description:

Not detailed description entered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 356
• Est. completion date: December 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Provision of written informed consent prior to any study specific procedures.

• ECOG Performance Status Score 0,1 or 2

• Adequate kidney, liver, bone marrow function according to laboratory tests

• For females of childbearing potential, a negative pregnancy test must be documented

• = 18 years old and <75 years old

• Colorectal cancer with peritoneal metastases

• All patients deemed eligible for CRS and HIPEC according to clinical routine management during a HIPEC multidisciplinary board at each respective hospital can be included.

Exclusion Criteria:

• Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil

• Unable to tolerate intensified HIPEC treatment due to comorbidity

• Metastasis other than peritoneum

• Pregnant or lactating (nursing) women

• Active infections requiring antibiotics

• Active liver disease with positive serology for active hepatitis B, C, or known HIV

• Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment

• Incomplete cytoreduction defined as completeness of cytoreduction score 1-3

• Histopathology of other origin than colorectal cancer

Related Conditions & MeSH terms

• Colorectal Cancer
• Fever
• Hyperthermia
• Peritoneal Metastases

Intervention

Drug:
• 5Fluorouracil
Injection of 250-850 mg/m2.
• Irinotecan
Injection of 360 mg/m2
• Oxaliplatin
Injection of 460 mg/m2

Locations

Country	Name	City	State
Sweden	Sahlgrenska östra sjukhuset	Gothenburg
Sweden	Skånes universitetssjukhus	Malmö
Sweden	Karolinska sjukhuset	Stockholm
Sweden	Akademiska sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	To study the recurrence-free survival (RFS) of patients	12 months after treatment
Secondary	Overall survival	Survival is followed through the HIPEC registry.	5 years after treatment
Secondary	Recurrence-free survival	Survival is followed through the HIPEC registry. The RECIST criteria are used to determine recurrence and site of first recurrence	5 years after treatment
Secondary	Postoperative complication rate	Morbidity is registered in the HIPEC registry within 30 days of treatment administration.	Within 30 days after treatment
Secondary	Patient evaluations of quality of life	EORTC QLQ questionnaire filled out at baseline, 12 and 36 months after surgery using the established QoL database.	3 years after treatment