Menu
Recruiting NCT04861558

Efficacy of Hyperthermic Intraperitoneal Chemotherapy

Phase III Interventional Colorectal Cancer Peritoneal Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5Fluorouracil, Irinotecan, Oxaliplatin.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Peritoneal Metastases. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India, Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Recurrence-free survival [Time frame: 24 months after treatment]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

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 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 4 centers
  • Sahlgrenska östra sjukhuset — Gothenburg
  • Skånes universitetssjukhus — Malmö
  • Karolinska sjukhuset — Stockholm
  • Akademiska sjukhuset — Uppsala
India · 1 center
  • INDEPSO — Ahmedabad

Identifiers

NCT: NCT04861558 · EFFIPECv5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗