Colorectal CancerPhase 3EFFIPECNCT04861558
Efficacy of Hyperthermic Intraperitoneal Chemotherapy
A Phase 3 study testing 5Fluorouracil, Irinotecan and Oxaliplatin in people with Colorectal Cancer and Peritoneal Metastases, run by Uppsala University at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colorectal Cancer, Peritoneal Metastases
- What is being tested?
- 5Fluorouracil, Irinotecan and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 May 2021to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 or liver or lung
- Complex liver-perenchymal sparing surgery or hemihepatectomy procedures are to be excluded.
- Previous CRS or HIPEC
- Pregnant or lactating (nursing) women
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- 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 2-3
- Histopathology of other origin than colorectal cancer
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska östra sjukhuset
Gothenburg
Elinor Bexe-Lindskog, MD,PhD, elinor.bexe_lindskog@vgregion.se
Elinor ö Bexe-Lindskog, MD, PhD
- Recruiting
Skånes universitetssjukhus
Malmö
Ingvar Syk, MD, PhD, ingvar_syk@telia.com
Ingvar Syk, MD, PhD
- Recruiting
Karolinska sjukhuset
Stockholm
Gabriella Jansson Palmer, gabriella.jansson-palmer@sll.se
Gabriella Jansson Palmer, MD, PhD
- Recruiting
Akademiska sjukhuset
Uppsala, 75185
Lana Ghanipour, lana.ghanipour@akademiska.se
Lana Ghanipour, MD, PhD
India1 site, 1 recruiting
- Recruiting
INDEPSO
Ahmedabad
Aditi Bhatt, MD, aditimodi31@gmail.com
About this study
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
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).
Read the detailed description
Not detailed description entered.
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Being tested
- 5Fluorouracil, Irinotecan, Oxaliplatin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5FluorouracilDrug
Also called Fluorouracil Accord, Fluorouracil Tevo
Injection of 250-850 mg/m2.
IrinotecanDrug
Also called Irinotecan Accord, Irinotecan Actavis, Irinotecan Fresenius Kabi
Injection of 360 mg/m2
OxaliplatinDrug
Also called Oxaliplatin Accord, Oxaliplatin Teva, Oxaliplatin Fresenius Kabi
Injection of 460 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Standard HIPEC | Active comparator | Injection of oxaliplatin 460 mg/m2 and an intraoperational IV of 5-fluorouracil 400 mg/m2, and calcium folinate 60 mg/m2. Receives: Drug: Oxaliplatin |
| Intensified HIPEC+EPIC | Experimental | 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. Receives: Drug: 5Fluorouracil; Drug: Irinotecan; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
To study the recurrence-free survival (RFS) of patients
Measured: 24 months after treatment
Secondary outcomes (4)
Overall survival
Survival is followed through the HIPEC registry.
Measured: 5 years after treatment
Recurrence-free survival
Survival is followed through the HIPEC registry. The RECIST criteria are used to determine recurrence and site of first recurrence
Measured: 5 years after treatment
Postoperative complication rate
Morbidity is registered in the HIPEC registry within 30 days of treatment administration.
Measured: Within 30 days after treatment
Patient evaluations of quality of life
EORTC QLQ questionnaire filled out at baseline, 12 and 36 months after surgery using the established QoL database.
Measured: 3 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 May 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Cashin, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861558
- Sponsor's protocol ID
- EFFIPECv5
- Acronym
- EFFIPEC
- Status last verified
- May 2025
- First submitted
- 6 Apr 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Completely anonymized IPD will be shared. All dates, HIPEC center treatment, referral city, and personal identification will be removed.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04861558
- Acronym / sponsor ID
- EFFIPEC / EFFIPECv5
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Not detailed description entered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard HIPEC | Active comparator | Drug: OxaliplatinInjection of oxaliplatin 460 mg/m2 and an intraoperational IV of 5-fluorouracil 400 mg/m2, and calcium folinate 60 mg/m2. |
| Intensified HIPEC+EPIC | Experimental | Drug: 5Fluorouracil, Drug: Irinotecan, Drug: OxaliplatinInjection 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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 or liver or lung
- Complex liver-perenchymal sparing surgery or hemihepatectomy procedures are to be excluded.
- Previous CRS or HIPEC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5FluorouracilAlso: Fluorouracil Accord, Fluorouracil TevoInjection of 250-850 mg/m2. | Drug | Intensified HIPEC+EPIC |
| IrinotecanAlso: Irinotecan Accord, Irinotecan Actavis, Irinotecan Fresenius KabiInjection of 360 mg/m2 | Drug | Intensified HIPEC+EPIC |
| OxaliplatinAlso: Oxaliplatin Accord, Oxaliplatin Teva, Oxaliplatin Fresenius KabiInjection of 460 mg/m2 | Drug | Intensified HIPEC+EPIC, Standard HIPEC |
Primary outcome
Recurrence-free survival
Time frame: 24 months after treatment
To study the recurrence-free survival (RFS) of patients
4 secondary outcomes
Overall survival
Time frame: 5 years after treatment
Recurrence-free survival
Time frame: 5 years after treatment
Postoperative complication rate
Time frame: Within 30 days after treatment
Patient evaluations of quality of life
Time frame: 3 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes. Completely anonymized IPD will be shared. All dates, HIPEC center treatment, referral city, and personal identification will be removed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Cashin, MD, PhD principal investigator
Uppsala University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5Fluorouracil, Irinotecan and Oxaliplatin in people with Colorectal Cancer and Peritoneal Metastases, run by Uppsala University at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Cashin, MD, PhD (+46 (0)18 6174304, peter.cashin@surgsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: 24 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.