BALLAD
Research type
Research Study
Full title
BALLAD. A trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma. The UK Component of the Global Ballad Pooled Data Analysis.
IRAS ID
122822
Contact name
Jeff Evans
Contact email
Sponsor organisation
Greater Glasgow and Clyde Health Board
Eudract number
2013-003047-29
ISRCTN Number
ISRCTN15070952
Duration of Study in the UK
9 years, 0 months, 1 days
Research summary
Small bowel adenocarcinoma is a rare cancer (less than 5% of gastrointestinal cancers). Some patients present with operable disease and undergo potentially curative surgery. However, approximately 50% of those patients who undergo surgical resection will develop recurrent, incurable disease, so there is a clear rationale to explore the use of post-operative (adjuvant) chemotherapy to determine if this can reduce the risk of recurrence, delay the time to recurrence (disease-free survival) and improve overall survival.
Currently, no standard post-operative chemotherapy regimen has been defined because of the absolute absence of randomised controlled trials in this disease and hence a reliance on retrospective review of single centre series, leading to a variation of practice internationally. This is the first adjuvant trial in small bowel adenocarcinoma developed through the International Rare Cancers Initiative.
Eligible patients, who have undergone potentially curative resection and in whom the benefits of post-operative chemotherapy are considered to be uncertain (investigator’s opinion), will be randomly allocated to receive post-operative chemotherapy or no chemotherapy (observation). For those patients in whom it is considered that the potential benefit of adjuvant chemotherapy is certain (and hence are not willing to accept randomisation to the ‘no chemotherapy’ arm), a randomisation between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin chemotherapy will be offered. These regimens are widely used in the management of large bowel cancer.
Those patients who do not consent to be randomised will be offered registration to allow collection of demographic, clinico-pathological and survival data, thereby making optimal use of the rare patient population available. In addition, archival tumour tissue (from the operation) and a blood sample will be collected from every registered patient to allow molecular profiling and future translational research. A questionnaire about underlying risk factors will also be given to all registered patients.
REC name
West of Scotland REC 1
REC reference
15/WS/0011
Date of REC Opinion
5 Mar 2015
REC opinion
Further Information Favourable Opinion