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

Who is this study for? Patients with Colorectal Cancer, Peritoneal Metastases
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

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

• ECOG Performance Status Score 0,1 or 2 alternatively Karnofsky 60-100

• 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 ≤78 years old

• Colorectal cancer with peritoneal metastases +/- liver metastases (maximum 3)

• Concomitant resectable pulmonary metastases are allowed

• 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.

Locations
Other Locations
India
INDEPSO
RECRUITING
Ahmedabad
Sweden
Sahlgrenska östra sjukhuset
RECRUITING
Gothenburg
Skånes universitetssjukhus
RECRUITING
Malmo
Karolinska sjukhuset
RECRUITING
Stockholm
Akademiska sjukhuset
RECRUITING
Uppsala
Contact Information
Primary
Peter Cashin, MD, PhD
peter.cashin@surgsci.uu.se
+46 (0)18 6174304
Backup
Lana Ghanipour, MD, PhD
lana.ghanipour@surgsci.uu.se
+46 (0)18 6110000
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2029-12
Participants
Target number of participants: 213
Treatments
Active_comparator: Standard HIPEC
Injection of oxaliplatin 460 mg/m2 and an intraoperational IV of 5-fluorouracil 400 mg/m2, and calcium folinate 60 mg/m2.
Experimental: Intensified HIPEC+EPIC
Injection of irinotecan 360 mg/m2 and 5-fluorouracil 24-hr EPIC 250-850 mg/m2 in combination with Oxaliplatin 360 mg/m2 and an intraoperational IV of 5-fluorouracil bolus 400 mg/m2 with calcium folinate 60mg/m2.~The EPIC treatment is given after the abdomen is completely sutured in the operating theater. The dose will be divided equally into 2 injections á 200ml each through two abdominal drains.
Related Therapeutic Areas
Sponsors
Leads: Uppsala University

This content was sourced from clinicaltrials.gov