Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
213 participants
INTERVENTIONAL
2021-05-01
2029-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard HIPEC
Injection of oxaliplatin 460 mg/m2 and an intraoperational IV of 5-fluorouracil 400 mg/m2, and calcium folinate 60 mg/m2.
Oxaliplatin
Injection of 460 mg/m2
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.
5Fluorouracil
Injection of 250-850 mg/m2.
Irinotecan
Injection of 360 mg/m2
Oxaliplatin
Injection of 460 mg/m2
Interventions
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5Fluorouracil
Injection of 250-850 mg/m2.
Irinotecan
Injection of 360 mg/m2
Oxaliplatin
Injection of 460 mg/m2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
79 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Peter Cashin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital
Locations
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INDEPSO
Ahmedabad, , India
Sahlgrenska östra sjukhuset
Gothenburg, , Sweden
Skånes universitetssjukhus
Malmo, , Sweden
Karolinska sjukhuset
Stockholm, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EFFIPECv5
Identifier Type: -
Identifier Source: org_study_id
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