Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
Locally advanced Gall bladders cancers not amenable for curative resection are often treated
with chemotherapy alone which is the current standard of care. Randomized trials have shown
survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is
not common western world and thus there is lack of evidence regarding the impact of
neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with
chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo
R0 resection in few published studies. Also if the patients develop distant metastasis during
this neoadjuvant therapy they can be spared of unnecessary surgery.
In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated
with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability
rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35
and 20 months for the patients undergoing R0 resection.
In this study the investigators intend to compare the effects of using neoadjuvant
chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall
bladder cancers in terms of down staging and overall survival.