Rectal Cancer Clinical Trial
Official title:
The Predictive Value of Cytokines on Response to Preoperative Chemoradiotherapy in Patients With Rectal Cancer
Rationale and background: Predictive factors are needed to discriminate chemoradiotherapy
responders from non-responders and to individualize the treatment regime. Various cytokines
play a role in processes affecting tumour growth and metastasis. Furthermore, cytokines
might influence treatment response. Various cytokines are abnormally expressed in colorectal
cancer patients, are associated with colorectal cancer or determine response to
chemoradiotherapy. Therefore the investigators want to investigate whether levels of
circulating cytokines could predict response to preoperative chemoradiotherapy in patients
with rectal cancer.
Hypothesis: The investigators hypothesis is that the varying levels of circulating cytokines
in the blood of rectal cancer patients may predict the response to preoperative
chemoradiotherapy.
Study design: This study is an explorative clinical pilot study in which the investigators
will collect 4 ml of blood from a selection of rectal cancer patients during a regular
venipuncture before, during and after preoperative chemoradiotherapy and before and after
surgery. Cytokines will be measured in blood plasma and in tumour and healthy tissue from
the resection specimen using multiplex immunoassays. Plasma cytokine measurements will be
linked to pathological response to identify which cytokines and corresponding levels can
predict response to preoperative chemoradiotherapy for patients with locally advanced rectal
cancer. Furthermore, blood plasma cytokine measurements before and after surgery will be
compared to evaluate the effect of tumour resection on the immune response. In addition,
preoperative blood plasma cytokine levels will be compared with cytokine levels in normal
and tumour tissue to test whether circulating cytokine levels are representative for tissue
cytokine levels.
Study population: Thirty patients (≥18 years) with locally advanced rectal adenocarcinoma
eligible for preoperative chemoradiotherapy (oral capecitabine and 45-50 gray (Gy) in total;
fractions of 1.8-2 Gy) and surgery.
Country of recruitment: The Netherlands
n/a
Observational Model: Cohort, Time Perspective: Prospective
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