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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 : June 25, 2018
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
medac GmbH
Cancer Research UK
Australasian Gastro-Intestinal Trials Group
Dutch Hepatocellular & Cholangiocarcinoma Group (DHCG)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Gall Bladder Carcinoma Drug: Gemcitabine Drug: Cisplatin Drug: Capecitabine Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 781 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2019
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
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)

and Observation

Drug: Gemcitabine
Gemcitabine 1000mg/m2

Drug: Cisplatin
Cisplatin 25mg/m2

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)

and Observation

Drug: Capecitabine
Capecitabine 1250mg/m2




Primary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: Disease free survival rate at 24 months (DFSR@24) ]
    DFS


Secondary Outcome Measures :
  1. Disease free survival rate at 24 months (DFSR@24) [ Time Frame: 24 months ]
    DSFR

  2. Recurrence free survival [ Time Frame: 24 months ]
    RFS

  3. Overall survival [ Time Frame: 84 months ]
    OS

  4. Safety and tolerability (assessed by the rate of patients with adverse events according to NCI CTC AE v4.03) [ Time Frame: 24 months ]
  5. Quality of life [ Time Frame: 48 months ]
    QOL

  6. Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD) [ Time Frame: 48 months ]
  7. Rate and severity of biliary tract infections [ Time Frame: 48 months ]
  8. Patterns of disease recurrence [ Time Frame: 48 months ]
  9. locoregional control (assessed by the rate of patients with hepatic or locoregional recurrence) [ Time Frame: 48 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Alexander Stein 004940741056882 a.stein@uke.de
Contact: Jun Li 004940741058572 j.li@uke.de

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Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Deutsche Krebshilfe e.V., Bonn (Germany)
medac GmbH
Cancer Research UK
Australasian Gastro-Intestinal Trials Group
Dutch Hepatocellular & Cholangiocarcinoma Group (DHCG)
Investigators
Principal Investigator: Henning Wege Universitätsklinikum Hamburg-Eppendorf

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02170090     History of Changes
Other Study ID Numbers: ACTICCA-1
2012-005078-70 ( EudraCT Number )
ACTRN12615001283561 ( Registry Identifier: ANZCTR (clinical trial registry) )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
adjuvant chemotherapy
cholangiocarcinoma
muscle invasive gall bladder carcinoma
translational research
multidisciplinary
AIO, DGAV, DGVS

Additional relevant MeSH terms:
Carcinoma
Cholangiocarcinoma
Urinary Bladder Neoplasms
Gallbladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Biliary Tract Neoplasms
Digestive System Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Gemcitabine
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors