Study on Gemcitabine and Cisplatin for Patients After Surgery for Bile Duct or Gallbladder Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients who have undergone surgery for two types of cancer: cholangiocarcinoma and muscle invasive gallbladder carcinoma. Cholangiocarcinoma is a cancer that occurs in the bile ducts, which are small tubes that carry bile from the liver to the small intestine. Muscle invasive gallbladder carcinoma is a type of cancer that affects the gallbladder and has spread into the muscle layer. The treatment being studied involves the use of two medications, gemcitabine and cisplatin, which are given after surgery to help prevent the cancer from coming back. These medications are compared to the standard care, which may include observation or another medication called capecitabine.

The purpose of this study is to evaluate how effective the combination of gemcitabine and cisplatin is compared to the standard care in preventing the return of cancer after surgery. Patients participating in the study will receive either the combination of gemcitabine and cisplatin or the standard care, which could be observation alone or capecitabine, depending on the stage of their cancer. The study will monitor patients over a period to see how well the treatment works in keeping the cancer from returning and to assess the overall health and quality of life of the patients.

Participants in the study will receive treatment for a set period, and their health will be closely monitored by healthcare professionals. The study aims to provide valuable information on the best treatment options for patients who have had surgery for cholangiocarcinoma or muscle invasive gallbladder carcinoma. By comparing the new treatment with the standard care, researchers hope to find the most effective way to help patients live longer without the cancer returning.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a confirmed diagnosis of certain types of cancer and recent surgical treatment.

Written informed consent is required before participation.

2 treatment phase

The treatment phase involves receiving adjuvant chemotherapy with gemcitabine hydrochloride and cisplatin.

Gemcitabine is administered as a solution for infusion through an intravenous route.

Cisplatin is also given as a solution for infusion intravenously.

The chemotherapy regimen is compared to the standard care, which may include observation or treatment with capecitabine tablets taken orally.

3 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and any side effects.

The primary goal is to evaluate disease-free survival and other outcomes such as overall survival and quality of life.

4 completion of the trial

The trial is expected to conclude by the end of 2025.

Final assessments will be made to determine the long-term benefits and safety of the treatment.

Who Can Join the Study?

Patients must have a type of cancer called adenocarcinoma of the biliary tract or muscle invasive gallbladder carcinoma. This means cancer that starts in the glands of the bile ducts or gallbladder.
Patients should be scheduled for surgery aimed at completely removing the cancer.
Patients must provide written informed consent, which means they agree to participate after understanding the study details.
Patients should not have had any previous chemotherapy for biliary tract cancer.
Patients should not have had any other cancer in the last 3 years, except for certain types like non-melanoma skin cancer or treated cervical cancer.
Patients should not have serious heart problems, such as severe heart failure, recent heart attack, or unstable chest pain.
Patients should not have mental health issues that prevent them from understanding the study or giving consent.
Patients should not have serious medical conditions that could affect their ability to participate in the study.
Women who can have children and men who can father children must agree to use effective birth control methods.
Women should not be pregnant or breastfeeding.
Patients must be at least 18 years old.
Patients must have good blood health, meaning enough white blood cells, platelets, and hemoglobin.
Patients must have good liver function, which is checked by certain blood tests.
Patients must have good kidney function, which is also checked by blood tests.
Patients should not have any active, uncontrolled infections, except for chronic viral hepatitis if they are receiving treatment for it.
Patients should not be taking other experimental drugs or cancer treatments within 30 days before starting the study.
Women who are not yet menopausal or are less than a year into menopause must have a negative pregnancy test before starting the study.
For a specific part of the study involving radiotherapy, patients must have a microscopic positive margin (R1) and no previous radiotherapy to the abdomen.

Who Cannot Join the Study?

Patients who have not had surgery to remove their cancer with the goal of curing it.
Patients with signs of cancer spreading to other parts of the body, known as metastatic disease.
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Jena KöR	Jena	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Universitaetsklinikum Aachen AöR	Aachen	Germany
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Clinical Trial Center Maastricht B.V.	Maastricht	The Netherlands
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Saarland University Hospital	Homburg	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Universita’ Di Pisa	Pisa	Italy
Klinik Favoriten	Vienna	Austria
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uskmurffeh Mwwltco Cuiaab Hrluepgfdpqiriucv	Hamburg	Germany
Uccrcesqobemrtlwxhjoj Exxgf Aea	Essen	Germany
Eiskagn Ucsitxalbjhn Mlfzete Curqkkt Rrdblfetb (dshhfel Mow	Rotterdam	The Netherlands
Afpgjhowa Ucd	Amsterdam	The Netherlands
Gmulls Uoqpjmygan Fbcepbfzv	Frankfurt	Germany
Koetnbmx dzx Uclllfsmwknm Mohwjfuj Aab	Munich	Germany
Uwfzbgyhuallkuhltphku Wcmgnwghr Asc	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	02.01.2014
Germany	Not recruiting	02.01.2014
Italy	Not recruiting	02.01.2014
The Netherlands	Not recruiting	02.01.2014

Trial locations

Investigated drugs:

Gemcitabine is a medication used in this trial to help prevent the return of cancer after surgery. It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body.

Cisplatin is another medication used in the trial alongside gemcitabine. It helps to kill cancer cells by damaging their DNA, which prevents them from dividing and growing.

Capecitabine is a medication that is used in the trial as part of the standard care in stage 2. It is an oral chemotherapy drug that is converted into another drug called 5-fluorouracil in the body, which helps to stop cancer cells from growing and dividing.

Investigated diseases:

Cholangiocarcinoma

Cholangiocarcinoma – Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It can occur in different parts of the bile duct system, including intrahepatic (inside the liver), hilar (where the bile ducts exit the liver), or distal (closer to the small intestine). The disease often progresses slowly and may not show symptoms until it is advanced. As it develops, it can cause jaundice, abdominal pain, and weight loss. The cancer can spread to nearby tissues and organs, making it more challenging to treat as it progresses.

Gallbladder Carcinoma – Gallbladder carcinoma is a cancer that originates in the gallbladder, a small organ beneath the liver that stores bile. This type of cancer is often discovered at a late stage because it may not cause noticeable symptoms early on. As the disease progresses, it can lead to symptoms such as abdominal pain, nausea, and jaundice. The cancer can invade nearby organs and tissues, complicating treatment efforts. It is more common in individuals with a history of gallstones or chronic gallbladder inflammation. The progression of the disease can vary, but it typically involves the spread to surrounding areas.

Trial ID:

2024-517340-61-00

Protocol code:

ACTICCA-1

NCT ID:

NCT02170090

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Gemcitabine and Cisplatin for Patients After Surgery for Bile Duct or Gallbladder Cancer

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