CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 348 target
Drug / intervention
Oxaliplatin intravenous +7 moredrug
Likely dose
Oxaliplatin intravenous 85 mgfrom record
Key inclusion· 8
  • Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
  • At least one measurable hepatic metastasis according to RECIST v1.1
  • No other metastatic sites except lung nodules if ≤3 and <10 mm
  • RAS mutation status known (KRAS and NRAS exons 2,3,4)
Key exclusion· 23
  • Contraindications to KTHIA installation: hepatic artery thrombosis or arterial anatomy compromising secondary resection
  • Immediately eligible for curative therapy (surgical/percutaneous)
  • Myocardial infarction, angina, or coronary surgery in past 6 months
  • Congestive heart failure NYHA class II, III or IV in past 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02885753
NCT02885753Phase 3RecruitingOn TrackUpdated 11mo ago
Long Recruiting

Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

Federation Francophone de Cancerologie Digestive·interventional·Posted Aug 31, 2016·Updated Jul 9, 2025

In Brief

A Phase 3 clinical trial evaluating Oxaliplatin intravenous, 5 FU bolus, and 6 other interventions for Colorectal Neoplasms. Currently recruiting, targeting 348 participants across 49 sites in 2 countries.

Detailed Summary

Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival. The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance. In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France
Collaborators--

Timeline

Phase 3Recruiting
2017201820192020202120222023202420252026202720282029
First PostedAug 31, 2016
Enrollment StartDec 1, 2016
Primary CompletionSep 1, 2028
TodayJul 2, 2026
Enrollment to primary: 11.8 yearsPosted 9.8 years agoPrimary completion in 2.2 years

Interventions

Oxaliplatin intravenousdrug

85 mg/m² in intravenous. 1 cycle each 15 days

5 FU bolusdrug

5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous) following by 2400 mg/m² during 46 hours in intravenous

Folinic aciddrug

400 mg/m² in intravenous

Oxaliplatin intra-arterieldrug

85 mg/m² in intra-arterial. 1 cycle each 15 days

Panitumumabdrug

Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous

Bevacizumabdrug

5 mg/kg at each cycle in intravenous

5 FU continuousdrug

2400 mg/m² intravenously over 46 hours

Irinotecandrug

150 mg/m² intravenous