Protocol Title

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)

Aim

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).

Background

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.

Patients Recruited

Click to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Contact Email

Principal Investigator

Dr Jenny Shannon (Nepean Hospital, Kingswood NSW)

More Information

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.

Funding

Australasian Gastro-Intestinal Trials Group
Cancer Australia