Efficacy of Hyperthermic Intraperitoneal Chemotherapy

Launched by UPPSALA UNIVERSITY · Apr 26, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment approach for patients with colorectal cancer that has spread to the lining of the abdomen, known as peritoneal metastases. The study aims to compare two treatment methods: one using standard chemotherapy with oxaliplatin and another using a combination of oxaliplatin, irinotecan, and a medication called 5-FU, which will be given after surgery. Participants will undergo a surgical procedure called cytoreductive surgery (CRS) to remove tumors, followed by one of these chemotherapy treatments. The trial will collect information on how well these treatments work and monitor patients for up to three years after treatment, with the possibility of extending this follow-up to five years.

To be eligible for this trial, participants must be between 18 and 75 years old, have a good overall health score, and have colorectal cancer with peritoneal metastases. They should not have any severe allergies to the chemotherapy drugs being used, nor should they have other significant health issues that could make this treatment unsafe. Participants can expect to receive a detailed evaluation and may be randomized to one of the two treatment groups during their surgery. This means they might not know which treatment they are receiving, but both are considered standard care. Overall, this trial is designed to improve treatment options for colorectal cancer patients facing this challenging condition.

Gender

ALL

Eligibility criteria

• 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