Gallbladder & Biliary Tract
If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.
The aim of ACTICCA-1 is to determine whether treating patients with a chemotherapy combination of cisplatin and gemcitabine following surgery for cancer of the biliary tract helps to reduce cancer recurrence.
Even though biliary tract cancer is uncommon, incidence and mortality rates are increasing in most developed countries.
ACTICCA-1 is a clinical research study for people who have cancer of the biliary tract (that is, cancer of the gall bladder or bile duct, also known as cholangiocarcinoma) which has been removed in an operation.
Cholangiocarcinoma is an uncommon type of cancer that develops in the bile ducts (tubes that drain bile to help with the digestion of food). There are only a few hundred new cases diagnosed in Australia each year so there are still many questions on the best way to treat this cancer. The most common and standard treatment for cholangiocarcinoma is surgery (that is, surgical resection) followed by chemotherapy with capecitabine, but surgery is only possible if the cancer has not spread beyond the bile duct. Despite this, there is still a risk of the cancer returning after surgery.
ACTICCA-1 is a randomised multicentre phase 3 trial that was initially designed to assess if giving chemotherapy after surgery is a better option for patients with Biliary Tract Cancer (cholangiocarcinoma and muscle invasive gallbladder carcinoma) compared to no chemotherapy after surgery. Recently, the trial has been amended to compare patients who receive one type of chemotherapy versus another type of chemotherapy after surgery. The trial will monitor for side effects of treatment and investigate whether the cancer is less likely to recur in one group or the other.
The results could help improve survival and quality of life for people with this type of cancer.
Gallbladder & Biliary Tract
If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.
Efficacy and safety of adjuvant chemotherapy with gemcitabine and cisplatin compared to capecitabine after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1)
The primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin compared with capecitabine treatment in patients with BTC after complete resection in terms of DFS.
Secondary objectives are safety and tolerability of the treatment as well as OS, recurrence free survival, quality of life, function of biliodigestive anastomoses, and evaluation of the quantity and quality of information patients have gained after the informed consent as well as of the involvement of patients in the decision-making process (shared decision making).
Biliary tract cancer is an uncommon cancer, with only a few hundred new cases diagnosed in Australia each year. Current standard treatment is surgery followed by adjuvant chemotherapy with capecitabine. but this can only be applied when the cancer is localised and resectable. Cancers commonly recur after surgery. Therefore, therapies that can improve the survival of patients need to be investigated.
Chemotherapy drugs, specifically cisplatin and gemcitabine, have been shown to be the most effective chemotherapy combination in advanced biliary tract cancer. Unfortunately, randomised data on the efficacy of adjuvant treatment after resection of biliary tract cancers are scarce. The UK biliary tract study team presented the results of the UK Bilcap trial at the recent American Society of Clinical Oncology Conference in June 2017. This trial showed a survival benefit for the oral chemotherapy agent capecitabine when compared with observation in patients following surgery for biliary tract cancer. This oral chemotherapy agent has now been adopted as a new standard of care following curative intent surgery for this disease.
ACTICCA-1 is a clinical research study for people who have a cancer of the biliary tract (cancer of the gall bladder or bile duct, also known as cholangiocarcinoma) which has been removed in an operation. In this study, patients will receive chemotherapy (cisplatin and gemcitabine, or capecitabine) after surgery in order to assess rates of disease recurrence as well as any associated side effects.
The findings of this study may provide details on which is the better treatment following surgery for cancer of the biliary tract. Whether giving a combination of cisplatin and gemcitabine or single agent capecitabine is the safer and most effective treatment to reduce the chance of disease recurrence and increase survival time and quality of life.
Clinical Trial Design
Eligible participants will be randomly allocated to receive either chemotherapy with cisplatin and gemcitabine or capecitabine. The study treatment will commence 6 to 16 weeks post-surgery.
Combination chemotherapy (gemcitabine and cisplatin) will be administered via intravenous infusion on day 1 and 8 every 3 weeks for 8 cycles, unless cancer recurrence or intolerable toxicity intervene.
Patients allocated to receive capecitabine will take the tablet for two weeks on and one week off, for a total of 8 cycles, unless cancer recurrence or intolerable toxicity intervene.
After treatment, patients will be assessed by CT or MRI every 3 months for two years after the initial 24 weeks. This will be followed by a 6-monthly abdominal ultrasound for a further 3 years. In total the study will follow patients for 5 years.
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Key Eligibility Criteria
Please note that the information below contains only the most important inclusion and exclusion criteria and is not a comprehensive list.
Key inclusion criteria:
- Adults (18 years or over) with histologically confirmed adenocarcinoma of the biliary tract that has been resected in the previous 6 – 12 weeks
- Adequate liver, kidney and blood function
- No active uncontrolled infection, except for chronic viral hepatitis on anti-viral therapy
- Not participating in concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomisation
- Willing to follow all study requirements, including treatment, timing and/or nature of required assessments and follow-up
- Signed, written informed consent
Key exclusion criteria:
- Prior chemotherapy for biliary tract cancer
- Previous malignancy within 3 years or concomitant malignancy
- Severe or uncontrolled cardiovascular disease
- Serious pre-existing medical conditions that could impair the ability of the patient to participate in the trial
- Pregnancy or lactation
Visit ANZTCR for more detailed information on inclusion/exclusion criteria and eligibility.
Dr Jenny Shannon (Nepean Hospital, Kingswood NSW)
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.
Australasian Gastro-Intestinal Trials Group