Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin (DELTIC)

Tracking Information
First Submitted Date ICMJE	July 17, 2012
First Posted Date ICMJE	July 24, 2012
Last Update Posted Date	February 14, 2018
Study Start Date ICMJE	July 2012
Estimated Primary Completion Date	July 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 19, 2012)	Tumor response according to modified RECIST Criteria [ Time Frame: 10 Weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01648023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 17, 2013)	Hepatic Progression Free Survival [ Time Frame: Progression ]
Original Secondary Outcome Measures ICMJE; (submitted: July 19, 2012)	Hepatic Progression Free Survival
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
Official Title ICMJE	Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carboplatin With Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Brief Summary	The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Unresectable Intrahepatic Cholangiocarcinoma
Intervention ICMJE	Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo; Drug: Gem-Cis or Gem-Carbo
Study Arms	Experimental: Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo Intervention: Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo; Active Comparator: Randomization to Gem-Cis or Gem-Carbo Gem-Cis or Gem-Carbo alone Intervention: Drug: Gem-Cis or Gem-Carbo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: July 19, 2012)	48
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	July 2020
Estimated Primary Completion Date	July 2020 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion: Patients over 18 years of age, of any race or sex, who have histologic and radiologic evidence of intrahepatic cholangiocarcinoma, who have been deemed unresectable by an experienced hepatic surgeon, and who are able to give informed consent, will be eligible; Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST criteria); Patients with liver-dominant disease defined as ≥80% tumor burden confined to the liver; Non-pregnant with an acceptable contraception in premenopausal women.; Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L, INR ≤1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to DEBIRI and meet INR criteria); Adequate liver function as measured by: Total bilirubin ≤ 2.0 mg/dl,; Adequate renal function (creatinine ≤ 2.3 mg/dl); Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG for women of child-bearing age); Signed, written informed consent; Less than 70% of liver parenchymal tumor replacement Exclusion: Patient eligible for curative treatment (i.e. resection or tumor ablation).; Active bacterial, viral or fungal infection within 72 hours of study entry; Women who are pregnant or breast feeding; ECOG Performance Status score of >3; Life expectancy of < 3 months; Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated; Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous cell carcinoma of the skin.; Any contraindication for hepatic embolization procedures:; Large shunt as determined by the investigator (pretesting with TcMMA not required); Severe atheromatosis vascular disease that precludes arterial cannulization; Hepatofugal blood flow; Main portal vein occlusion (e.g. thrombus or tumor); Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation; Patients with prior contraindications for the use of irinotecan, gemcitabine, or cisplatin; Patients who have received prior systemic therapy with either irinotecan, gemcitabine, or cisplatin
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Mary Healey, CCRC 502-629-3327 mary.healey@louisville.edu Contact: Robert Martin, MD, PhD 502-629-3355 robert.martin@louisville.edu
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01648023
Other Study ID Numbers ICMJE	11-0181
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Robert C. Martin, University of Louisville
Study Sponsor ICMJE	Robert C. Martin
Collaborators ICMJE	University of Louisville
Investigators ICMJE	Principal Investigator: Robert Martin, MD, PhD University of Louisville
PRS Account	University of Louisville
Verification Date	December 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP