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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02170090




Registration number
NCT02170090
Ethics application status
Date submitted
18/06/2014
Date registered
23/06/2014
Date last updated
5/12/2023

Titles & IDs
Public title
Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer
Scientific 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)
Secondary ID [1] 0 0
2012-005078-70
Secondary ID [2] 0 0
ACTICCA-1
Universal Trial Number (UTN)
Trial acronym
ACTICCA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholangiocarcinoma 0 0
Gall Bladder Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Treatment: Drugs - Capecitabine

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)
and Observation

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)
and Observation


Treatment: Drugs: Gemcitabine
Gemcitabine 1000mg/m2

Treatment: Drugs: Cisplatin
Cisplatin 25mg/m2

Treatment: Drugs: Capecitabine
Capecitabine 1250mg/m2
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease free survival (DFS)
Timepoint [1] 0 0
Disease free survival rate at 24 months (DFSR@24)
Secondary outcome [1] 0 0
Disease free survival rate at 24 months (DFSR@24)
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Recurrence free survival
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
84 months
Secondary outcome [4] 0 0
Safety and tolerability (assessed by the rate of patients with adverse events according to NCI CTC AE v4.03)
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Quality of life
Timepoint [5] 0 0
48 months
Secondary outcome [6] 0 0
Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD)
Timepoint [6] 0 0
48 months
Secondary outcome [7] 0 0
Rate and severity of biliary tract infections
Timepoint [7] 0 0
48 months
Secondary outcome [8] 0 0
Patterns of disease recurrence
Timepoint [8] 0 0
48 months
Secondary outcome [9] 0 0
locoregional control (assessed by the rate of patients with hepatic or locoregional recurrence)
Timepoint [9] 0 0
48 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
Accrual to date
Final
789
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Bankstown Hospital - Bankstown
Recruitment hospital [2] 0 0
Nepean Hospital Cancer Care - Kingswood
Recruitment hospital [3] 0 0
St. George Hospital - Kogarah
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 0 0
Townsville Hospital - Douglas
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 0 0
Fiona Stanley Hospital Perth - Murdoch
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [12] 0 0
St. John of God - Subiaco
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Kingswood
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- Waratah
Recruitment postcode(s) [6] 0 0
- Douglas
Recruitment postcode(s) [7] 0 0
- Herston
Recruitment postcode(s) [8] 0 0
- Woolloongabba
Recruitment postcode(s) [9] 0 0
- Bedford Park
Recruitment postcode(s) [10] 0 0
6150 - Murdoch
Recruitment postcode(s) [11] 0 0
- Nedlands
Recruitment postcode(s) [12] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Denmark
State/province [2] 0 0
Vejle
Country [3] 0 0
Germany
State/province [3] 0 0
Aachen
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Dresden
Country [6] 0 0
Germany
State/province [6] 0 0
Essen
Country [7] 0 0
Germany
State/province [7] 0 0
Esslingen
Country [8] 0 0
Germany
State/province [8] 0 0
Frankfurt
Country [9] 0 0
Germany
State/province [9] 0 0
Freiburg
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg
Country [11] 0 0
Germany
State/province [11] 0 0
Hannover
Country [12] 0 0
Germany
State/province [12] 0 0
Heidelberg
Country [13] 0 0
Germany
State/province [13] 0 0
Homburg
Country [14] 0 0
Germany
State/province [14] 0 0
Jena
Country [15] 0 0
Germany
State/province [15] 0 0
Mainz
Country [16] 0 0
Germany
State/province [16] 0 0
Mannheim
Country [17] 0 0
Germany
State/province [17] 0 0
Munich
Country [18] 0 0
Germany
State/province [18] 0 0
Regensburg
Country [19] 0 0
Germany
State/province [19] 0 0
Tuebingen
Country [20] 0 0
Germany
State/province [20] 0 0
Ulm
Country [21] 0 0
Germany
State/province [21] 0 0
Wuerzburg
Country [22] 0 0
Italy
State/province [22] 0 0
Milano
Country [23] 0 0
Italy
State/province [23] 0 0
Padova
Country [24] 0 0
Italy
State/province [24] 0 0
Pisa
Country [25] 0 0
Italy
State/province [25] 0 0
Rome
Country [26] 0 0
Netherlands
State/province [26] 0 0
Amsterdam
Country [27] 0 0
Netherlands
State/province [27] 0 0
Maastricht
Country [28] 0 0
Netherlands
State/province [28] 0 0
Rotterdam
Country [29] 0 0
Netherlands
State/province [29] 0 0
Utrecht
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Basingstoke
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Birmingham
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Bournemouth
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Bristol
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Cambridge
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Cardiff
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Edinburgh
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Glasgow
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Great Yarmouth
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Guildford
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Harlow
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Huddersfield
Country [43] 0 0
United Kingdom
State/province [43] 0 0
London
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Maidstone
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Nottingham
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Oxford
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Plymouth
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Sheffield
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Southampton
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Other
Name
Universitätsklinikum Hamburg-Eppendorf
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Deutsche Krebshilfe e.V., Bonn (Germany)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cancer Research UK
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australasian Gastro-Intestinal Trials Group
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Dutch Cancer Society
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02170090
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henning Wege
Address 0 0
Universitätsklinikum Hamburg-Eppendorf
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02170090