Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006427

Trial Description

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Title

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)

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Trial Acronym

ACTICCA-1

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URL of the Trial

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Brief Summary in Lay Language

This is a multicentre, prospective, randomized, controlled phase III trial designed to
assess the clinical performance of gemcitabine with cisplatin and observation vs.
observation alone in patients after curative intent resection of cholangiocarcinoma and
muscle invasive gall bladder carcinoma.

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Brief Summary in Scientific Language

The ACTICCA-1 investigator initiated trial is funded by the Deutsche Krebshilfe (grant
number 110215) and supported my medac. With respect to data obtained in the ABC-02 trial,
the combination of cisplatin and gemcitabine for 24 weeks as investigational treatment was
selected. Based on adjuvant trials in pancreatic cancer (e.g. ESPAC IV) with a comparable
postoperative recovery time, inclusion of patients within a maximum interval of 16 weeks
between surgery and start of CTx was chosen. Due to the different prognosis and treatment
susceptibility of muscle invasive carcinoma, two separate cohorts for CCA and GBCA were
included to capture the expected treatment effects. Randomization will be stratified for
lymph node status for both cohorts and localization for CCA. The primary endpoint is DFS and
secondary endpoints include OS, safety and tolerability of adjuvant CTx, quality of life,
and patterns of disease recurrence. In both cohorts, randomization will be 1:1 with adjuvant
CTx for 24 weeks and imaging every 12 weeks in the experimental arm and observation only in
the control arm.

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Organizational Data

  •   DRKS00006427
  •   2014/08/01
  •   2014/06/18
  •   yes
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Secondary IDs

  •   NCT02170090  (ClinicalTrials.gov)
  •   2012-005078-70 
  •   ACTICCA-1  (Universitätsklinikum Hamburg-Eppendorf)
  •   2012-005078-70 
  •   ACTRN12615001283561 
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Health Condition or Problem studied

  •   Cholangiocarcinoma
  •   Gall Bladder Carcinoma
  •   C22.1 -  Malignant neoplasm: Intrahepatic bile duct carcinoma
  •   C24.0 -  Malignant neoplasm: Extrahepatic bile duct
  •   C24.8 -  Malignant neoplasm: Overlapping lesion of biliary tract
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Interventions/Observational Groups

  •   Drug: Gemcitabine
  •   Drug: Cisplatin
  •   Other: Observation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Disease free survival (DFS); time frame: Disease free survival rate at 24 months (DFSR@24)

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Secondary Outcome

- Disease free survival rate at 24 months (DFSR@24); time frame: 24 months
- overall survival; time frame: 84 months
- Safety and tolerability (assessed by the rate of patients with adverse events according to NCI CTC AE v4.03); time frame: 24 months
- Quality of life; time frame: 48 months
- Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD); time frame: 48 months
- Rate and severity of biliary tract infections; time frame: 48 months
- Patterns of disease recurrence; time frame: 48 months
- locoregional control (assessed by the rate of patients with hepatic or locoregional recurrence); time frame: 48 months

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Countries of Recruitment

  •   Australia
  •   Germany
  •   Netherlands
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/04/30
  •   440
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

All enrolled patients will postoperatively be assessed for eligibility for the treatment
phase. Additionally patients not previously enrolled into the trial for whatever reason
(e.g. incidental finding during surgery) will be evaluated for eligibility.

- Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or
extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after
radical surgical therapy with macroscopically complete resection (mixed tumor
entities (HCC/CCA) are excluded)

- Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start
of chemotherapy

- ECOG 0-1

- Age >18 years

- Adequate hematologic function

- Adequate liver function

- Adequate renal function

- No active uncontrolled infection, except chronic viral hepatitis under antiviral
therapy

- No concurrent treatment with other experimental drugs or other anti-cancer therapy,
treatment in a clinical trial within 30 days prior to randomization

- Negative serum pregnancy test within 7 days of starting study treatment in
pre-menopausal women and women <1 year after the onset of menopause (Note: a negative
test has to be reconfirmed by a urine test, should the 7-day window be exceeded)

Criteria for initial study enrolment

- Written informed consent

- No prior chemotherapy for cholangiocarcinoma

- No previous malignancy within 3 years or concomitant malignancy, except:
non-melanomatous skin cancer or adequately treated in situ cervical cancer

- No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III
or IV, unstable angina pectoris, history of myocardial infarction in the last 3
months, significant arrhythmia)

- Absence of psychiatric disorder precluding understanding of information of trial
related topics and giving informed consent

- No serious underlying medical conditions (judged by the investigator), that could
impair the ability of the patient to participate in the trial

- Fertile women (< 1 year after last menstruation) and procreative men willing and able
to use effective means of contraception (oral contraceptives, intrauterine
contraceptive device, barrier method of contraception in conjunction with spermicidal
jelly or surgically sterile)

- No pregnancy or lactation

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Exclusion Criteria

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf
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    • Deutsche Krebshilfe e.V., Bonn (Germany)
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    • medac GmbH
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    • Cancer Research UK
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    • AGITG Australasian Gastro Intestinal Trials Group
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    • KWF Kanker Bestrijding The Netherlands
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    • Universitätsklinikum Hamburg-Eppendorf
    • Henning Wege 
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    • Alexander Stein 
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    •   004940741056882
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    •   a.stein at uke.de
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2016/07/17
* This entry means the parameter is not applicable or has not been set.