The Predictive Value of Cytokines on Response to Preoperative Chemoradiotherapy in Patients With Rectal Cancer (CYTORECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02077296|
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : September 9, 2016
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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||34 participants|
|Official Title:||The Predictive Value of Cytokines on Response to Preoperative Chemoradiotherapy in Patients With Rectal Cancer|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
The group consists of patients aged ≥18 with a pathohistological diagnosis of locally advanced rectal adenocarcinoma (<15 cm from the anal verge). They are found eligible for preoperative chemoradiotherapy (chemotherapy: oral capecitabine / radiotherapy: 45-50 Gy in total; fractions of 1.8-2 Gy) and surgery (stage 2 or 3 rectal cancer).
- Plasma and tissue cytokine levels [ Time Frame: 20 weeks ]Patients will be followed for the duration of preoperative chemoradiotherapy until 6 weeks after surgery
Biospecimen Retention: Samples Without DNA
An extra ethylene diamine tetra acetic acid blood tube of 4 ml will be withdrawn from the patient during a regular venapuncture or after administration of an intravenous needle specifically before, during and just after preoperative CRT, 1 day before and 2 days after surgery and 6 weeks after surgery. Blood samples for determination of cytokines are directly processed.
As standard medical treatment surgery will be performed and biopsies of resection specimen will be collected by the department of pathology, frozen, and further examined. For this study 4 extra biopsies will be taken from resection tissue for cytokine measurements. Two from tumour tissue and 2 from normal mucosa of each patient. These biopsies will be snap-frozen in liquid nitrogen. Subsequently, the frozen biopsies will be grinded with a mortar and pestle, which were cooled in liquid nitrogen, and resuspended in 100 μl ice-cold PBS containing 10 μl/ml of a cocktail of protease inhibitors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077296
|St. Antonius Hospital|
|Nieuwegein, Utrecht, Netherlands, 3435 CM|
|Principal Investigator:||Maartje Los, MD, PhD||St. Antonius Hospital|
|Principal Investigator:||Niels Van Lelyveld, MD, PhD||St. Antonius Hospital|
|Principal Investigator:||G.T. Rijkers, MD, PhD, Prof||St. Antonius Hospital|
|Principal Investigator:||Lotte Jacobs, MD||St. Antonius Hospital|