Topic: BILCAP-A Randomized trial by UK for capecitabine for resected CC pt
I went over the materials from ASCO 6.2011.I found this BILCAP poster study which may be of interest to those CC patients in UK. It was funded by the UK cancer research since 2006. This is a randomized trial evaluating adjuvant therapy with Xeloda(capecitabine) compared to expectant treatment alone following curative surgery for biliary tract cancer(BTC).
This study is on target to complete accrual early in 2013.Trial recruitment remain strong 225 pts of 360 have been successfully recruited to date;
The primary endpoint is progression free survival(DFS) at 2 years and the intention is to increase 2 year DFS from 15 % to 28%.Secondary end points are 5 years survival (12 month survival rate of 86.4% at the time of this interim analysis),toxicity (hand and foot Grade1,2=65% and GI toxicity most prevalent,as anticipated;no Grade 4 toxicities observed to date and all the toxicities are within expected levels.)and quality of life.the result will define the international standard of care for resected BTC patients.
The treatment arm dose of Capecitabine is 1250mg/m2,for total of 8 cycles.
Toxicity(Grade1-2) and Grade3-4 in () include:
1.Fatigue=71% (13%) 2. Fever=13%(0%) 3.Weight loss=13%(0%)
4. hand-foot reaction=65%(15%) 5.Diarrhea=54%(10%)
6. Mucositis/Stomatitis=41% (1%) 7. Nausea=48% (1%)8.Vomiting=20%(0%).
100 patients who are on Capecitabine have returned 571 treatment forms.