Efficacy of Hyperthermic Intraperitoneal Chemotherapy (EFFIPEC)

May 26, 2025 updated by: Uppsala University

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Not detailed description entered.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska östra sjukhuset
        • Contact:
        • Principal Investigator:
          • Elinor ö Bexe-Lindskog, MD, PhD
      • Malmö, Sweden
        • Recruiting
        • Skånes universitetssjukhus
        • Contact:
        • Principal Investigator:
          • Ingvar Syk, MD, PhD
      • Stockholm, Sweden
        • Recruiting
        • Karolinska Sjukhuset
        • Contact:
        • Principal Investigator:
          • Gabriella Jansson Palmer, MD, PhD
      • Uppsala, Sweden, 75185
        • Recruiting
        • Akademiska sjukhuset
        • Contact:
        • Principal Investigator:
          • Lana Ghanipour, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 (maximum 3)
  7. Concomitant resectable pulmonary metastases are allowed
  8. 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:

  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
  4. Complex liver-perenchymal sparing surgery or hemihepatectomy procedures are to be excluded.
  5. Previous CRS or HIPEC
  6. Pregnant or lactating (nursing) women
  7. Active infections requiring antibiotics
  8. Active liver disease with positive serology for active hepatitis B, C, or known HIV
  9. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment
  10. Incomplete cytoreduction defined as completeness of cytoreduction score 2-3
  11. Histopathology of other origin than colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Oxaliplatin
Injection of 460 mg/m2
Other Names:
  • Oxaliplatin Accord
  • Oxaliplatin Teva
  • Oxaliplatin Fresenius Kabi
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.
Drug: Oxaliplatin
Injection of 460 mg/m2
Other Names:
  • Oxaliplatin Accord
  • Oxaliplatin Teva
  • Oxaliplatin Fresenius Kabi
Drug: 5Fluorouracil
Injection of 250-850 mg/m2.
Other Names:
  • Fluorouracil Accord
  • Fluorouracil Tevo
Drug: Irinotecan
Injection of 360 mg/m2
Other Names:
  • Irinotecan Accord
  • Irinotecan Actavis
  • Irinotecan Fresenius Kabi

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 24 months after treatment
To study the recurrence-free survival (RFS) of patients
24 months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years after treatment
Survival is followed through the HIPEC registry.
5 years after treatment
Recurrence-free survival
Time Frame: 5 years after treatment
Survival is followed through the HIPEC registry. The RECIST criteria are used to determine recurrence and site of first recurrence
5 years after treatment
Postoperative complication rate
Time Frame: Within 30 days after treatment
Morbidity is registered in the HIPEC registry within 30 days of treatment administration.
Within 30 days after treatment
Patient evaluations of quality of life
Time Frame: 3 years after treatment
EORTC QLQ questionnaire filled out at baseline, 12 and 36 months after surgery using the established QoL database.
3 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Cashin, MD, PhD, Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFFIPECv5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Completely anonymized IPD will be shared. All dates, HIPEC center treatment, referral city, and personal identification will be removed.

IPD Sharing Time Frame

To be shared at the time of phase 3 trial publication. Available for 10 years.

IPD Sharing Access Criteria

Access by request only from the corresponding author. Study protocol, SAP, ICF will be publicly available without request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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