Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy or in Front of Radical Resection of BTC (ICC/ECC) - A Phase III Study of the German Registry of Incidental Gallbladder Carcinoma Platform (GR) - The AIO/ CALGP/ ACO- GAIN-Trial - (GAIN)

  • STATUS
    Recruiting
  • End date
    Nov 14, 2024
  • participants needed
    300
  • sponsor
    Krankenhaus Nordwest
Updated on 14 September 2022
antibiotics
renal function
carcinoma
international normalized ratio
metastasis
gemcitabine
aptt
psychiatric disorder
adjuvant chemotherapy
cholangiocarcinoma
cisplatin/gemcitabine
gallbladder carcinoma
biliary tract cancer

Summary

Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC)

Description

The aim of the study is to investigate whether induction chemotherapy followed by radical re-resection (and - if possible - postoperative chemotherapy) in incidental gallbladder carcinoma (IGBC) or in front radical resection in biliary tract cancer (BTC) (intrahepatic cholangiocarcinoma (ICC)/ extrahepatic cholangiocarcinoma (ECC)) prolongs overall survival without impaired quality of life compared to immediate radical surgery alone with or without adjuvant chemotherapy (investigator's choice) in patients with IGBC, or BTC (ICC/ECC). One of the most important secondary objectives is to raise awareness for the necessity of a radical second surgery as well as to improve the adherence to the treatment guidelines in IGBC. Further secondary objectives are safety and tolerability of the treatment as well as quality of life.

Details
Condition Incidental Gallbladder Carcinoma, Biliary Tract Cancer
Treatment cisplatin, Gemcitabine, Adjuvant chemotherapy, Oncologically radical margin-free (R0) resection
Clinical Study IdentifierNCT03673072
SponsorKrankenhaus Nordwest
Last Modified on14 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
No prior partial or complete tumor resection for BTC (intrahepatic, hilar or distal CCA), and for IGBC/GBC prior Cholecystectomy is allowed
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
ECOG performance status of 0, 1, or 2
Estimated life expectancy > 3 months
Female and male patients1 ≥18 years
Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
No previous or preceding cytotoxic or targeted therapy for BTC or IGBC/GBC
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
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)
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
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
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
No pregnancy or lactation
abstinent or to use a condom for the duration of the pregnancy
Adequate hematologic function: ANC ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 9 g/dl or ≥ 5.59 mmol/L; prior transfusions for patients with low hemoglobin are allowed
Adequate liver function as measured by serum transaminases (AST and ALT) ≤ 5 x ULN and bilirubin ≤ 3 x ULN
Adequate renal function, i.e. serum creatinine ≤ 1.5 x institutional ULN, a calculated glomerular filtration rate ≥ 30 mL/min
Adequate coagulation functions as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Patients receiving warfarin/ phenprocoumon must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to randomization
No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy (patients on long-term antibiotics are eligible provided signs of active infection have been resolved)
No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days or five half-lives (whichever is longer) 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 Please note that after randomization for patients in Arm A the histological confirmation of BTC or GBC must be performed before administering chemotherapy. For IGBC histological confirmation should already have been performed
For Arm B patients the histological confirmation can be performed after surgery with
material from the surgery

Exclusion Criteria

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
Radiological evidence suggesting inability to resect with curative intent whilst
maintaining adequate vascular inflow and outflow, and sufficient future liver
remnant
Known hypersensitivity against gemcitabine or cisplatin
Other known contraindications to gemcitabine or cisplatin
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
Clinically significant valvular defect
agents
History of deep vein thrombosis, pulmonary embolism, or any other significant
Locally unresectable tumor or metastatic disease
thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis
are not considered "significant") during 3 months prior to randomization
Radiological evidence of direct invasion into adjacent organs
Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a
Radiological evidence of extrahepatic metastatic disease
history of hepatic encephalopathy or ascites
Other severe internal disease or acute infection
On-treatment participation in another clinical study 30 days or five half-lives
Chronic inflammatory bowel disease
(whichever is longer) prior to inclusion and during the study
Pregnant or breast feeding patient, or patient is planning to become pregnant within 7
months after the end of treatment
Patients in a closed institution according to an authority or court decision (AMG §
Abs. 1 No. 4)
Any other concurrent antineoplastic treatment including irradiation
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