Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer (ACTICCA-1)
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|ClinicalTrials.gov Identifier: NCT02170090|
Recruitment Status : Recruiting
First Posted : June 23, 2014
Last Update Posted : September 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma Gall Bladder Carcinoma||Drug: Gemcitabine Drug: Cisplatin Drug: Capecitabine||Phase 3|
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.
In addition, eligible patients with R1 resection included in sites participating in the radiotherapy sub-study will be randomized between 24 weeks chemotherapy (gemcitabine/cisplatin or capecitabine) or 18 weeks of chemotherapy (gemcitabine/cisplatin or capecitabine) followed by chemoradiation with capecitabine.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||781 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2023|
Experimental: Gemcitabine plus 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)
Second randomisation for R1 resected patients: 8 cycles Cisplatin and Gemcitabin or 6 cycles Cisplatin and Gemcitabin followed by IMRT with capecitabine
Active Comparator: 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)
Second randomisation for R1 resected patients: 8 cycles capecitabine or 6 cycles capecitabine followed by IMRT with capecitabine
- Disease free survival (DFS) [ Time Frame: Disease free survival rate at 24 months (DFSR@24) ]DFS
- Disease free survival rate at 24 months (DFSR@24) [ Time Frame: 24 months ]DSFR
- Recurrence free survival [ Time Frame: 24 months ]RFS
- Overall survival [ Time Frame: 84 months ]OS
- 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 ]QOL
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170090
|Contact: Alexander Steinemail@example.com|
|Contact: Jun Lifirstname.lastname@example.org|
|Principal Investigator:||Henning Wege||Universitätsklinikum Hamburg-Eppendorf|