Clinical Trial Details

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

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Trial Information

Broad Health Condition Cholangiocarcinoma
Gall Bladder Carcinoma

Specific Health Condition


Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,

Hospital
Bankstown Hospital
Nepean Hospital Cancer Care
St. George Hospital
Prince of Wales Hospital
Townsville Hospital
Royal Brisbane and Women's Hospital
Princess Alexandra Hospital
Fiona Stanley Hospital Perth
Sir Charles Gairdner Hospital

Phase of TrialPhase 3

Trial 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 including an embedded sub-study for R1 resected patients
receiving additional chemoradiation.
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

  Additional eligibility criteria for patients to be included in the radiotherapy substudy:

    -  R1 (microscopic positive margin)

    -  no previous radiotherapy to abdomen

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Universitätsklinikum Hamburg-Eppendorf

Trial websitehttps://clinicaltrials.gov/show/NCT02170090

Trial IDNCT02170090