Investigation of combined chemotherapy for patients with complete resection of cholangiocarcinoma or muscle invasive gallbladder carcinoma.

Phase 1

• Conditions: Cholangiocarcinoma and gallbladder carcinoma; MedDRA version: 18.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0Level: LLTClassification code 10017620Term: Gallbladder carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005078-70-GB
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-20
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Eligibility criteria for enrolment phase
1.Suspicion of or histologically/cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic biliary tract cancer, or muscle invasive gallbladder cancer) scheduled for radical surgical therapy
2.Written informed consent
3.No prior chemotherapy for biliary tract cancer
4.No previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
5.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)
6.Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
7.No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
8.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)
9.No pregnancy or lactation
Eligibility criteria for treatment phase (before randomisation)
1.Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic biliary tract cancer or muscle invasive gallbladder cancer) after radical surgical therapy with macroscopically complete resection (mixed hepatocellular tumours are excluded)
2.Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start of chemotherapy
3.ECOG 0-1
4.Age >18 years
5.Adequate haematologic function: ANC =1.5 x 109/L, platelets =100 x109/L, haemoglobin =9 g/dl or =5.59 mmol/L
6.Adequate liver function as measured by serum transaminases (AST and ALT) =5 x ULN and bilirubin =3 x ULN
7.Adequate renal function, i.e. serum creatinine =1.5 x ULN, glomerular filtration rate = 60 mL/min (MDRD)
8.No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
9.No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomisation
10.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)
11.Written informed consent
12.No prior chemotherapy for biliary tract cancer
13.No previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
14.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)
15.Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
16.No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
17.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

Exclusion Criteria

Mixed hepatocellular tumours are excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified