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NCT Number: NCT04861558

Efficacy of Hyperthermic Intraperitoneal Chemotherapy

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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Peritoneal Metastases Rectal Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

INDEPSO, Ahmedabad, India

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About this study

Not detailed description entered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5Fluorouracil

Drug

Injection of 250-850 mg/m2.

Other names: Fluorouracil Accord, Fluorouracil Tevo

Irinotecan

Drug

Injection of 360 mg/m2

Other names: Irinotecan Accord, Irinotecan Actavis, Irinotecan Fresenius Kabi

Oxaliplatin

Drug

Injection of 460 mg/m2

Other names: Oxaliplatin Accord, Oxaliplatin Teva, Oxaliplatin Fresenius Kabi

Primary outcomes

  1. Recurrence-free survival

    Time frame: 24 months after treatment

    To study the recurrence-free survival (RFS) of patients

Secondary outcomes

  1. Overall survival

    Time frame: 5 years after treatment

    Survival is followed through the HIPEC registry.

  2. 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

  3. Postoperative complication rate

    Time frame: Within 30 days after treatment

    Morbidity is registered in the HIPEC registry within 30 days of treatment administration.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lana Ghanipour, MD, PhD

CONTACT

[email protected]

+46 (0)18 6110000

Peter Cashin, MD, PhD

CONTACT

[email protected]

+46 (0)18 6174304

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Acronym: EFFIPEC

Important dates

Study start
2021
Primary completion
2025
Study completion
2029
First posted
Apr 27, 2021
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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