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New treatment option for Colorectal Cancer
Official title Liver Transplantation and Colorectal Cancer
ClinicalTrials.gov ID: NCT01479608
What this study is testing
- What it's testing
- Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped.
- 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 and older
You may be able to join if
- Histologically verified adenocarcinoma in colon or rectum.
- No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan.
- No signs of extra hepatic metastatic disease or local recurrence according to CT or MR (thorax/abdomen/pelvis) scan within 4 weeks prior to the...
- No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit
- Good performance status, ECOG 0 or 1.
You likely can't join if
- Weight loss \>10% the last 6 months
- Patient BMI \> 30
- Other malignancies
- Prior extra hepatic metastatic disease or local relapse.
- Patients who have not received standard pre-operative, per-operative or post-operative treatment for the primary CRC.
- Palliative resection of primary CRC tumor.
See the full eligibility criteria
- Histologically verified adenocarcinoma in colon or rectum.
- No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan.
- No signs of extra hepatic metastatic disease or local recurrence according to CT or MR (thorax/abdomen/pelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit
- No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit
- Good performance status, ECOG 0 or 1.
- Satisfactory blood tests Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<2 x upper normal level, ASAT,ALAT\<5 x upper normal level, ,Creatinine \<1.25 x upper normal level. Albumin above lower...
- Standard surgical procedure with adequate resection margins including circumferential resection margins (CRM) of at least ≥2mm for rectal cancer patients.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations.
- Received at least 3 cycles of chemotherapy (6 weeks of treatment), with no increase in size of the lesions according to RECIST-criteria Additional for patients included in part A: \- Six or more liver metastases...
- Metachronous liver metastases (more than 12 months from diagnosis of CRC and/or end of adjuvant treatment)
- Pathological classification of primary tumor as pN0 disease.
- CEA\<100 ng/ml at time of primary diagnosis as well as at time of diagnosis of metastatic disease.
- Liver metastases not eligible for curative liver resection.
- Before start of 1. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less.
- At least 10% response (RECIST-criteria) on 1. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 1. line chemotherapy. Additional for patients included in part C:
- Liver metastases not eligible for curative liver resection.
- Received 1.line treatment.
- Before start of 2. or 3. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less.
- At least 10% response (RECIST-criteria) on 2. or 3. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 2. or 3. line chemotherapy.
- Two years or more time span from the CRC diagnosis and date of being listed on the transplantation list. Additional for patients included in part Arm D: Patients with expected overall survival of 6-12 months without a...
- Weight loss \>10% the last 6 months
- Patient BMI \> 30
- Other malignancies
- Prior extra hepatic metastatic disease or local relapse.
- Patients who have not received standard pre-operative, per-operative or post-operative treatment for the primary CRC.
- Palliative resection of primary CRC tumor.
- Previous randomization in this trial.
- Any reason why, in the opinion of the investigator, the patient should not participate.
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. 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.