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Tests treatment safety and results for Colorectal Cancer
Official title Efficacy of Hyperthermic Intraperitoneal Chemotherapy
ClinicalTrials.gov ID: NCT04861558
What this study is testing
What is 5Fluorouracil?
5Fluorouracil is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for colorectal cancer.
Also referred to as Fluorouracil Accord, Fluorouracil Tevo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ahmedabad, India
- Gothenburg, Sweden
- Malmö, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ahmedabad, India; Gothenburg, Sweden; Malmö, Sweden; Stockholm, Sweden; Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.