BridgeMD
EFFIPEC
EU CTIS ID: 2024-516224-34-00
What this study is testing
Phase I: To determine the maximum tolerated dose of 5-Fluorouracil 24-hour EPIC, in combination with intensified oxaliplatin/irinotecan HIPEC, for treatment of colorectal cancer. Phase III: To study the recurrence-free survival (RFS) of patients within 24 months
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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.
- Colorectal cancer with peritoneal metastases +/- liver metastases.
You likely can't join if
- Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil
- Histopathology of other origin than colorectal cancer.
- Unable to tolerate intensified HIPEC treatment due to comorbidity.
- Metastasis other than peritoneum or liver or lung (ie paraaortal lymph node or bone metastases)
- 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.
- Concomitant resectable pulmonary metastases.
- All patients deemed eligible for CRS and HIPEC according to clinical routine.
- Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil
- Histopathology of other origin than colorectal cancer.
- Unable to tolerate intensified HIPEC treatment due to comorbidity.
- Metastasis other than peritoneum or liver or lung (ie paraaortal lymph node or bone metastases)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- India
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India. 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 EU CTIS; the study team decides eligibility.