Adjuvant Chemotherapy with Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer
- Conditions
- Gall Bladder CarcinomaCholangiocarcinoma
- Interventions
- Registration Number
- NCT02170090
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.
- Detailed Description
The ACTICCA-1 investigator initiated trial is funded by the Deutsche Krebshilfe (grant number 70110215, 70112047). 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 had to be established.
Therefore, the ACTICCA trial was 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 was 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 789
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine plus Cisplatin Gemcitabine Chemotherapy will be administered on days 1 and 8 every 3 weeks, Cisplatin (25 mg per square meter of body-surface area) and Gemcitabine (1000 mg per square meter) for 24 weeks (8 cycles) and Observation Gemcitabine plus Cisplatin Cisplatin Chemotherapy will be administered on days 1 and 8 every 3 weeks, Cisplatin (25 mg per square meter of body-surface area) and Gemcitabine (1000 mg per square meter) for 24 weeks (8 cycles) and Observation Capecitabine Capecitabine Capecitabine will be administered from day 1 to 14 every 3 weeks (1250 mg per square meter of body-surface area, twice daily) for 24 weeks (8 cycles) and Observation
- Primary Outcome Measures
Name Time Method Disease free survival (DFS) Disease free survival rate at 24 months (DFSR@24) DFS
- Secondary Outcome Measures
Name Time Method Recurrence free survival 24 months RFS
Disease free survival rate at 24 months (DFSR@24) 24 months DSFR
Safety and tolerability (assessed by the rate of patients with adverse events according to NCI CTC AE v4.03) 24 months locoregional control (assessed by the rate of patients with hepatic or locoregional recurrence) 48 months Rate and severity of biliary tract infections 48 months Patterns of disease recurrence 48 months Overall survival 84 months OS
Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD) 48 months Quality of life 48 months QOL
Trial Locations
- Locations (65)
Bankstown Hospital
🇦🇺Bankstown, New South Wales, Australia
Nepean Hospital Cancer Care
🇦🇺Kingswood, New South Wales, Australia
St. George Hospital
🇦🇺Kogarah, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Townsville Hospital
🇦🇺Douglas, Queensland, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Princess Alexandra Hospital
🇬🇧Harlow, United Kingdom
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Fiona Stanley Hospital Perth
🇦🇺Murdoch, Western Australia, Australia
Scroll for more (55 remaining)Bankstown Hospital🇦🇺Bankstown, New South Wales, Australia