Clincosm LogoSign in Get a demo

SIRCCA: SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

Sponsor
Sirtex Medical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02807181
Collaborator
(none)
89
Enrollment
23
Locations
2
Arms
69
Anticipated Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

This clinical study is a prospective, multicenter, randomized, controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine (CIS-GEM) chemotherapy vs. CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma.

Randomized patients will be followed until death, withdrawal of consent, or until end of study.

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Cisplatin-gemcitabine
Systemic chemotherapy
Other Names:
  • CIS-GEM

    		•
    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.

    Drug: Cisplatin-gemcitabine
    Systemic chemotherapy
    Other Names:
  • CIS-GEM

    • Device: Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
    SIR-Spheres microspheres followed by systemic chemotherapy

    Outcome Measures

    Primary Outcome Measures

    1. Survival at 18 months [18 months following the date of randomization.]

      Survival at 18 months is defined as the proportion of patients still alive 18 months from the date of randomization.

    Secondary Outcome Measures

    1. Liver-specific progression free survival (PFS) [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..]

    2. Progression free survival (PFS) at any site [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.]

    3. Objective response rate by RECIST 1.1 and refined RECIST - liver [From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months.]

    4. Objective response rate by RECIST 1.1 and refined RECIST - at any site [From the date of first treatment until progression at any site, assessed up to 36 months.]

    5. Overall Survival [From date of randomization until the date of death from any cause, assessed up to 36 months.]

    6. Liver surgical resection and ablation rate [18 months following the date of randomization.]

      To assess the number of patients in each arm who are downstaged by protocol therapy and can proceed to liver resection or ablation. The specific assessments will be the classification of resection as R0, R1 or R2, the presence of viable tumor or fibrosis, and the nearest resection margin.

    7. Incidence of Adverse Events (Safety and tolerability) [Informed consent until 28 days post last dose of protocol chemotherapy.]

      Adverse events as assessed by CTCAE v. 4.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 109/L Absolute neutrophil count (ANC) >/= 1.5 x 109/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.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Health Care Spokane Washington United States 99204
    2 Macquarie University Hospital North Ryde New South Wales Australia 2109
    3 Peter MacCallum Cancer Centre Melbourne Victoria Australia 3000
    4 Cliniques Universitaires Saint-Luc Brussels Belgium 1200
    5 Hopital Beaujon Clichy France 92110
    6 CHU Dijon Dijon France 21079
    7 CHU de Grenoble Grenoble France 38043
    8 CHU Lyon - Hospital de la Croix-Rousse Lyon France 69317
    9 Institut Paoli Calmettes Marseille France 13009
    10 CHU Montpellier Montpellier France 34295
    11 CHU Nice - Hopital l'Archet 2 Nice France 06202
    12 Hopital Haut-Leveque Pessac Cedex France 33604
    13 CHU de Poitiers Poitiers France 86021
    14 Centre Eugene Marquis Hospital de Jour Rennes France 35042
    15 Hopital Paul Brousse Villejuif France 94800
    16 U.O. Oncologia Medica 2 Universitaria Pisa Italy 56126
    17 AMC Academic Medical Center Amsterdam Netherlands 1105
    18 Hospital Clinic Barcelona Barcelona Spain 08036
    19 Clinica Universitaria de Navarra Pamplona Spain 31008
    20 Hammersmith Hospital Imperial College Healthcare NHS Trust London United Kingdom W12 0HS
    21 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX
    22 Southampton General Hospital Southampton United Kingdom S016 6YD
    23 The Clatterbridge Cancer Centre NHS Foundation Trust Wirral United Kingdom CH63 4JY

    Sponsors and Collaborators

    • Sirtex Medical

    Investigators

    • Principal Investigator: Jordi Bruix, MD, Head of the Hepatic Oncology Unit, Hospital Clinic
    • Principal Investigator: Harpreet Wasan, MD, Imperial College Healthcare Hammersmith Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sirtex Medical
    ClinicalTrials.gov Identifier:
    NCT02807181
    Other Study ID Numbers:
    • STX0115
    First Posted:
    Jun 21, 2016
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Cholangiocarcinoma
    Gemcitabine
    Cisplatin

    Study Results

    No Results Posted as of Apr 4, 2022