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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02807181




Registration number
NCT02807181
Ethics application status
Date submitted
13/05/2016
Date registered
21/06/2016

Titles & IDs
Public title
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Scientific title
Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Secondary ID [1] 0 0
STX0115
Universal Trial Number (UTN)
Trial acronym
SIRCCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intrahepatic Cholangiocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cisplatin-gemcitabine
Treatment: Devices - Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)

Active comparator: Chemotherapy (Cisplatin-Gemcitabine) - Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.

Experimental: Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine) - A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.


Treatment: Drugs: Cisplatin-gemcitabine
Systemic chemotherapy

Treatment: Devices: Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
SIR-Spheres microspheres followed by systemic chemotherapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival at 18 months
Timepoint [1] 0 0
18 months following the date of randomization.
Secondary outcome [1] 0 0
Liver-specific progression free survival (PFS)
Timepoint [1] 0 0
From date of randomization to the first documented date of progression in the liver or date of death from any cause, assessed up to 36 months..
Secondary outcome [2] 0 0
Progression free survival (PFS) at any site
Timepoint [2] 0 0
From date of randomization to the date of progression at any site until the first date of documented tumor progression at any site or date of death from any cause, assessed up to 36 months.
Secondary outcome [3] 0 0
Objective response rate by RECIST 1.1 and refined RECIST - liver
Timepoint [3] 0 0
From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months.
Secondary outcome [4] 0 0
Objective response rate by RECIST 1.1 and refined RECIST - at any site
Timepoint [4] 0 0
From the date of first treatment until progression at any site, assessed up to 36 months.
Secondary outcome [5] 0 0
Overall Survival
Timepoint [5] 0 0
From date of randomization until the date of death from any cause, assessed up to 36 months.
Secondary outcome [6] 0 0
Liver surgical resection and ablation rate
Timepoint [6] 0 0
18 months following the date of randomization.
Secondary outcome [7] 0 0
Incidence of Adverse Events (Safety and tolerability)
Timepoint [7] 0 0
Informed consent until 28 days post last dose of protocol chemotherapy.

Eligibility
Key inclusion criteria
* Willing, able and mentally competent to provide written informed consent.
* Aged 18 years or older.
* Histologically or cytologically confirmed unresectable and non-ablatable intrahepatic cholangiocarcinoma.
* Liver-only or liver predominant intrahepatic cholangiocarcinoma. Patient are permitted to have loco-regional lymph node involvement defined as: portal LN </= to 2 cm and/or para aortic LN </= to 1.5 cm in longest diameter, and/or up to 2 indeterminate lung lesions < 1 cm if these lung lesions are positron emission tomography (PET) negative.
* Chemotherapy naïve. Adjuvant chemotherapy is not permitted.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Adequate hematological function defined as:

Hemoglobin >/= 10g/dL White Blood Cell count (WBC) >/= 3.0 x 10^9/L Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L Platelet count >/= 100,000/mm^3 - Adequate liver function defined as: Total bilirubin </= 30 umol/L (1.75 mg/dL) Albumin >/= 30 g/L

- Adequate renal function defined as: Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN) Creatinine clearance >/= 45 ml/min (calculated with Cockcroft-Gault Equation)

* Life expectancy of at least 3 months without any active treatment
* Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active use an acceptable method of contraception during the study.
* Male patients must be surgically sterile or if sexually active must use an acceptable method of contraception during the study.
* Considered suitable to receive either regimen in the clinical judgement of the treating investigator.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with only non-measurable lesions in the liver according to RECIST criteria
* Incomplete recovery from previous liver surgery, e.g. unresolved biliary tree obstruction or biliary sepsis or inadequate liver function
* Biliary stent in situ
* Main trunk Portal Vein Thrombosis (PVT)
* Ascites, even if controlled with diuretics. (A minor peri-hepatic rim of ascites detected at imaging is acceptable).
* Mixed hepatocellular carcinoma - intrahepatic cholangiocarcinoma (HCC-ICC) disease
* History of prior malignancy. Exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, recurrent intra-hepatic cholangiocarcinoma post local treatment or any early stage (stage 1) malignancy adequately resected with curative intent at least 5 years prior to study entry
* Suspicion of any bone metastasis/metastases or central nervous system metastasis/metastases on clinical or imaging examination.
* Prior internal or external radiation delivered to the liver.
* Pregnancy; breast feeding.
* Participation within 28 days prior to randomization, in an active part of another clinical study that would compromise any of the endpoints of the study.
* Evidence of ongoing active infection that may affect treatment feasibility or outcome.
* Prior Whipple's procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2022
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - North Ryde
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Washington
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
France
State/province [3] 0 0
Clichy
Country [4] 0 0
France
State/province [4] 0 0
Dijon
Country [5] 0 0
France
State/province [5] 0 0
Grenoble
Country [6] 0 0
France
State/province [6] 0 0
Lyon
Country [7] 0 0
France
State/province [7] 0 0
Marseille
Country [8] 0 0
France
State/province [8] 0 0
Montpellier
Country [9] 0 0
France
State/province [9] 0 0
Nice
Country [10] 0 0
France
State/province [10] 0 0
Pessac Cedex
Country [11] 0 0
France
State/province [11] 0 0
Poitiers
Country [12] 0 0
France
State/province [12] 0 0
Rennes
Country [13] 0 0
France
State/province [13] 0 0
Villejuif
Country [14] 0 0
Italy
State/province [14] 0 0
Pisa
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Pamplona
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Manchester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Southampton
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sirtex Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jordi Bruix, MD
Address 0 0
Head of the Hepatic Oncology Unit, Hospital Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02807181