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New treatment option for Colorectal Cancer
Official title Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
ClinicalTrials.gov ID: NCT02864485
What this study is testing
- What it's testing
- Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor prognosis. In patients with resectable disease, surgery offers a distinct survival benefit.
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 68
You may be able to join if
- Must reside in Canada
- ECOG ( Eastern Cooperative Oncology Group) score : 0-1 at all times prior to LDLT (excursions to ECOG 2 allowed at investigator's discretion)
- Proven colorectal Liver Metastases (LM).
- Willing and able to provide written informed consent.
- Negative serum pregnancy test for women of childbearing potential
You likely can't join if
- Previous or concurrent cancer (with some exceptions)
- prior lung resection
- Progression of LM at any timepoint prior to transplant surgery
- Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
- Pulmonary insufficiency
- History of cardiac disease
See the full eligibility criteria
- Must reside in Canada
- ECOG ( Eastern Cooperative Oncology Group) score : 0-1 at all times prior to LDLT (excursions to ECOG 2 allowed at investigator's discretion)
- Proven colorectal Liver Metastases (LM).
- Willing and able to provide written informed consent.
- Negative serum pregnancy test for women of childbearing potential
- Both men and women must agree to use adequate barrier birth control measures during the course of the trial.
- At least 1 "acceptable", ABO-compatible living donor has stepped forward
- Primary Colorectal cancer tumor stage is ≤T4a
- Time from primary CRC resection to transplant is ≥6 months
- Bilateral and non-resectable LM
- No major vascular invasion by LM; metastases isolated to liver
- The patient has undergone systemic chemotherapy (eg. FOLFOX +/- bevacizumab or FOLFIRI +/- bevacizumab) for ≥3 months
- demonstrated stability or regression of LM over at minimum the 3 months preceding screening
- Carcinoembryonic Antigen (CEA) values are stable or decreasing at all timepoints prior to the transplant surgery.
- Previous or concurrent cancer (with some exceptions)
- prior lung resection
- Progression of LM at any timepoint prior to transplant surgery
- Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
- Pulmonary insufficiency
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B and/or C infection.
- Patients with debilitating neuropathy. (CTCAE \> grade 2)
- BRAF + tumors
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 68 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. 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.