COLOVERT – Conversion therapy in colorectal cancer with peritoneal metastases not amenable to upfront cytoreductive surgery and HIPEC: a phase II “pick-the-winner” open-label randomized trial
Key facts
- Where
- Gothenburg, Malmo, Solna és Uppsala, SvédországSee the 4 sites
- Phase
- 2. fázis
Where in Svédország
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGothenburg, SvédországToborzás még nem indult
- Region Skane Skanes UniversitetssjukhusMalmo, SvédországToborzás még nem indult
- Karolinska University HospitalSolna, SvédországToborzás még nem indult
- Uppsala University HospitalUppsala, SvédországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Uppsala University Hospital
- Trial code
- EU 2026-526122-41-00
- Record updated
- 2026. július 15.
- Original description
To compare the difference in objective response rates (ORR) between two experimental repeat intraperitoneal chemotherapy regimens.Read full original descriptionShow less
To compare the difference in objective response rates (ORR) between two experimental repeat intraperitoneal chemotherapy regimens.
Inclusion: 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 <80 years old • Colorectal cancer (>10cm from anal verge) with CT assessable synchronous or metachronous peritoneal metastases +/- primary tumor • CT-PCI > 10 (which translates often to surgical PCI >15) as judged at the HIPEC multidisciplinary board meeting but considered candidate for CRS/HIPEC in the case of significant tumor response. • CT-PCI < 10 allowed if conversion therapy is necessary to be eligible for CRS+/-HIPEC • RAS mutations and wild-type cancers can both be included. • No previous treatment for peritoneal metastatic disease.
Exclusion: Previous severe toxicity/allergic reactions to the systemic chemotherapy agents included in this study • Unable to tolerate full dose systemic chemotherapy treatment due to comorbidity or previous remaining toxicity (e.g. neurotoxicity) or DPYD deficiency • Deficient mismatch repair cancers are excluded • Previous CRS or HIPEC or other large open abdominal surgery leading to significant intraperitoneal adhesions. (laparoscopic procedures are ok) • Previous severe abdominal septicemia or other causes that may significantly increase the risk of intraperitoneal adhesions (a staging laparoscopy may be allowed to determine this) • 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 • Lower and intermediate rectal cancers are excluded (above >10cm accepted) • Indication for preoperative radiation.