Status:
COMPLETED
Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Collaborating Sponsors:
Biocompatibles UK Ltd
Conditions:
Colorectal Cancer With Non Resectable Hepatic Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy. Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in te...
Eligibility Criteria
Inclusion
- Histologically proven colorectal adenocarcinoma,
- Liver metastases radiologically or histologically proven
- At least one measurable liver lesions by RECIST v1.1
- Age ≥ 18 years
- WHO Index \< or = 2
- Life expectancy ≥ 3 months
- No extrahepatic disease except lung nodules if number \< or = 3 and size \< 10 mm each
- Healthy liver \<60%
- Primary tumor resected or still in place
- No prior chemotherapy for metastases treatment (except a perioperative chemotherapy, if the last cycle was administered at least 12 months ago)
- Adjuvant chemotherapy after resection of the primary authorized if the last cycle was administered at least 12 months ago
- Normal hepatic function: total bilirubin ≤ 1.5 N; AST ≤ 5N; ALT ≤ 5N and PAL ≤ 5N
- TP ≥ 60%
- Adequate hematologic function: ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hb ≥ 9g/dl
- Good renal function: creatinine clearance ≥ 60 mL / min
- No cardiac dysfunction: no cardiovascular events in the last 6 months or no NYHA ≥ 2
Exclusion
- Patient eligible for curative treatment (resection and / or radiofrequency ablation) by a multidisciplinary decision (including the opinion of a liver surgeon)
- Pregnant or lactating woman or patients of both sexes and of childbearing age not using adequate contraception
- History of cancer, except skin cancer (other than melanoma), carcinoma in situ of the cervix uteri treated curative. Other cancers treated with curative intent are permitted provided they did not relapse over the last 5 years
- Peripheral neuropathy
- Inflammatory Bowel Diseases
- Intestinal obstruction
- Chronic liver disease (viral, alcoholic or metabolic)
- Immune Deficiency Syndromes (history of transplantation, infection with HIV)
- Known to have contraindications to 5FU, oxaliplatin, folinic acid, irinotecan or to contrast products
- Patients with known contraindications against hepatic embolization procedures:
- Presence of biliary-digestive anastomosis or biliary stent Cruoric or tumor thrombosis of the portal vein
- Patient who for psychological, social, family or geographical reasons could not be followed up regularly
- Legal disability (persons deprived of liberty or under guardianship)
- Patient is not affiliated to a social security scheme
- Participation in another concurrent study investigating the effect of treatment and this until 4 weeks after the end of the concurrent study.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01839877
Start Date
May 1 2013
End Date
January 1 2019
Last Update
October 8 2024
Active Locations (9)
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1
Hopital Saint André
Bordeaux, France, 33075
2
CHU - Hôpital François Mitterand
Dijon, France
3
Hôpital Prive Jean Mermoz
Lyon, France, 69008
4
Centre Léon Berard
Lyon, France, 69373