ACTICCA-1

Protocol title:   Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma

and muscle invasive gallbladder carcinoma.

International Sponsor: University Medical Center Hamburg-Eppendorf

Australian Sponsor: AGITG

Australian Study Chair: Dr Jenny Shannon (Nepean Hospital,  Kingswood NSW)

Associate Oncology Program Manager:  Cheryl Friend

Trial Coordinator:  Kate Walker

Contact Email: ACTICCA1@ctc.usyd.edu.au

Detailed information available on:   Australian and New Zealand Clinical Trials Registry – ACTICCA

Trial Newsletter: none to date

Grants Awarded:
GI Cancer Institute:  $43,380 (2014)
Cancer Australia: $497,544 (2016)

Aim:
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 Biliary Tract Cancer, specifically cholangiocarcinoma and muscle invasive gallbladder carcinoma.

Translational research will be performed to evaluate the prognostic and predictive impact of different blood and tissue markers in biliary tract cancer with particular regard of adjuvant chemotherapy with gemcitabine and cisplatin.

Background:
The incidence of biliary tract cancers varies extremely in different geographical regions, which reflects the variable distribution of local risk factors and genetic differences. For unknown reasons, incidence and mortality rates are increasing with in the last decades in most developed countries. Up to now, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma and is therefore the treatment of choice if deemed surgically resectable.

Unfortunately more than 50% of patients present with unresectable disease at the time of diagnosis. The prognosis at this stage is dismal, being approximately 3 months without intervention, and 4-6 months with palliative biliary decompression. Even after curative resection, the 5-year survival rate is only 20-40%.

Because of these high rates of disease recurrence and poor survival rates following radical surgery, postoperative treatment modalities eg. Chemotherapy, radiotherapy and chemoradiation, have been considered to improve patient survival after resection of bile duct cancers. Unfortunately, randomised data on the efficacy of adjuvant treatment after resection of cholangiocarcinomas are scarce.

Data from clinical trials and retrospective analyses suggest a benefit of the use of adjuvant treatment with either chemotherapy or chemoradiation. Therefore, the evaluation of adjuvant treatment in biliary tract cancer is urgently needed.

Study Design and Methods:

The ACTICCA-1 trial is a randomised, multi-disciplinary, multinational, phase III trial led by Dr Henning Wege at University Medical Centre, Hamburg-Eppendorf.   The AGITG and NHMRC Clinical Trials Centre will work in collaboration with the UMC Hamburg.

Eligible patients will be randomised to receive either gemcitabine and cisplatin plus observation, or observation only. Randomisation will be carried out centrally using a computer programme at CTC North (Germany). Patients will be randomised according to the following stratification factors

  • Cholangiocarcinoma cohort
    • Intrahepatic vs. hilar/extrahepatic CCA
    • Lymph node positivity vs. negativity
  • Muscle invasive gallbladder carcinoma cohort
    • Lymph node positivity vs. negativity

Approximately 65 international centres including 15 Australian centres are expected to participate in this trial. 440 participants will be recruited (280 in the cholangiocarcinoma arm and 160 in the muscle invasive gallbladder arm), of which 50 will come from Australia.

To view  Study Schema click here

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