Clinical Trial: Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Ch
Brief Summary: The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.
Detailed Summary:
Sponsor: Center Eugene Marquis
Current Primary Outcome: Radiological response rate to the treatment with the association of chemotherapy and radioembolization [ Time Frame: 3 months after radioembolization ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Tolerance of intra-hepatic administration of Yttrium 90-labelled microspheres in association with intravenous chemotherapy with Gemcitabine and Cisplatin assessed according NCI/CTC AE version 4. [ Time Frame: Up to 24 months ]Grade 3-4 toxicity appearance.Time between 1st treatment administration and date of 1st appearance of a grade 3-4 toxicity or date of last toxicities assessment in case no grade 3-4 toxicity
- Tumor markers changes (CA19.9, CEA and AFP) [ Time Frame: Up to 24 months ]Markers will be analysed every 8 weeks during treatment period and if applicable every 12 weeks after surgery
- Radiological response rate by the CHOI criteria [ Time Frame: Up to 24 months ]every 8 weeks and every 12 weeks after surgery if applicable
- Change in metabolic activity measured by TEP [ Time Frame: Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres ]
- Changes of liver volume [ Time Frame: Up to 24 months ]Every 8 weeks during treatment and every 12 weeks after surgery if applicable
- Tumoral and non-tumoral dosimetric assessment of the liver [ Time Frame: Up to 6 months ]Data obtained from SPECT/CT performed at each hepatic scintigraphy
Original Secondary Outcome: Same as current
Information By: Center Eugene Marquis
Dates:
Date Received: July 17, 2013
Date Started: September 2013
Date Completion: April 2018
Last Updated: December 2, 2016
Last Verified: December 2016