Brief Title: Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

INTRODUCTION

• Org Study ID: ACTICCA-1
• Secondary ID: 2012-005078-70, ACTRN12615001283561
• NTC ID: NCT02170090
• Sponsor: Universitätsklinikum Hamburg-Eppendorf

BRIEF SUMMARY

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

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DETAILED DESCRIPTION

The ACTICCA-1 investigator initiated trial is funded by the Deutsche Krebshilfe (grant number
70110215, 70112047) and supported by 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. Gemcitabine and cisplatin has a relevantly
higher cumulative dose of gemcitabine 18 vs. 12 applications and may thus be of increased
efficacy compared to the gemcitabine/oxaliplatin regimen applied in the PRODIGE 12 trial.

Based on the data of the BILCAP trial showing an improvement in median overall survival for
capecitabine compared to observation alone presented at the annual meeting of the American
Society of Clinical Oncology on June 4th 2017 in Chicago by the British BILCAP trial group,
capecitabine has evolved as the new standard of care after curative intent resection of
biliary tract cancer.

Based on these data the comparative efficacy of gemcitabine/cisplatin and capecitabine needs
to be established.

Therefore, the ACTICCA trial will be amended to compare gemcitabine and cisplatin to the
newly established standard regimen in the adjuvant setting capecitabine, aiming for
superiority of the combination regimen vs. the oral monotherapy This will be based on the
BILCAP protocol, applying the similar dosing, assessments and dose modifications as in
BILCAP, including dose calculation and patient diary.

As data of recent trials like the French PRODIGE 12/ACCORD 18 trial have clearly shown that
in terms of efficacy of an adjuvant chemotherapy there is no difference between
cholangiocarcinoma and gall bladder carcinoma, these two subtypes are pooled and location was
added as an stratification factor.

Randomization will be 1:1 with adjuvant CTx for 24 weeks and imaging every 12 weeks in the
experimental arm and standard of care (capecitabine) and observation in the control arm.

The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS,
safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.

• Overall Status
  Recruiting
• Start Date
  
• Phase
  Phase 3
• Study Type
  Interventional