Study in Gallbladder or bile duct cancer comparing chemotherapy with gemcitabine plus cisplatin before and after radical liver resection with direct radical liver resection followed by chemotherapy or no chemotherapy (physician's decision) - A Phase III study of the German Gallbladder Cancer Registry

Phase 1

Conditions: incidental gallbladder carcinoma (IGBC) or biliary tract cancer (BTC) (intrahepatic cholangiocarcinoma (ICC)/ extrahepatic cholangiocarcinoma (ECC))
MedDRA version: 21.1Level: LLTClassification code 10025734Term: Malignant neoplasm of biliary tract, part unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: LLTClassification code 10028982Term: Neoplasm biliary tractSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: HLTClassification code 10004675Term: Biliary tract and gallbladder therapeutic proceduresSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 20.0Level: PTClassification code 10017614Term: Gallbladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10061962Term: Gallbladder operationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-004444-38-AT

Lead Sponsor: Krankenhaus Nordwest gGmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Incidental gallbladder carcinoma (IGBC), gallbladder carcinoma (GBC) () or Biliary tract cancer (BTC) (intrahepatic, hilar or distal Cholangiocarcinoma (CCA)) scheduled for complete resection (mixed tumor entities with hepatocellular carcinoma are excluded).
2.No prior partial or complete tumor resection for BTC (intrahepatic, hilar or distal CCA), and for IGBC/GBC prior Cholecystectomy is allowed.
3.Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI, indicating an unresectable situation.
4.ECOG performance status of 0, 1, or 2.
5.Estimated life expectancy > 3 months.
6.Female and male patients =18 years.
7.Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
8.No previous or preceding cytotoxic or targeted therapy for BTC or IGBC/GBC.
9.No previous malignancy within two years or concomitant malignancy, except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer
10.No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last three months, significant arrhythmia).
11.Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent.
12.No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial.
13.A) Females of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 7 months after the last study treatment.
A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (has not had =12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

B) Males must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:
With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of 1% per year during the treatment period and for at least 6 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period. Men with a pregnant partner must agree to remain abstinent or to use a condom for the duration

Exclusion Criteria

1.Known hypersensitivity against gemcitabine or cisplatin
2.Other known contraindications to gemcitabine or cisplatin
3.Clinically significant valvular defect
4.Past or current history of other malignancies not curatively treated and without evidence of disease for more than two years, except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer
5.Locally unresectable tumor or metastatic disease:
-Radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow, and sufficient future liver remnant
-Radiological evidence of direct invasion into adjacent organs
-Radiological evidence of extrahepatic metastatic disease
6.Other severe internal disease or acute infection
7.Chronic inflammatory bowel disease
8.Receiving chronic antiplatelet therapy, including aspirin (Once-daily aspirin use (maximum dose 325 mg/day) is permitted), nonsteroidal anti-inflammatory drugs (including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents.
9.History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant”) during 3 months prior to randomization.
10.Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites.
11.On-treatment participation in another clinical study 30 days or five half-lives (whichever is longer) prior to inclusion and during the study
12.Pregnant or breast feeding patient, or patient is planning to become pregnant within 7 months after the end of treatment.
13.Patients in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)
14.Any other concurrent antineoplastic treatment including irradiation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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