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Cytokines as predictors on response to preoperative chemoradiotherapy in patients with rectal cancer


- candidate number16562
- NTR NumberNTR4450
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-feb-2014
- Secondary IDsNL46983.100.13/R13.044 ToetsingOnline/VCMO
- Public TitleCytokines as predictors on response to preoperative chemoradiotherapy in patients with rectal cancer
- Scientific TitleThe predictive value of cytokines on response to preoperative chemoradiotherapy in patients with rectal cancer
- ACRONYMCYTORECT
- hypothesisCancer and cancer treatment result in an inflammatory response thereby cytokines are produced. Cytokines may also themselves influence therapy response. Various cytokines are abnormally expressed in colorectal cancer patients, are associated with colorectal cancer or determine response to chemoradiotherapy. Our hypothesis is that the varying levels of these circulating cytokines in the blood of rectal cancer patients may predict the response to preoperative chemoradiotherapy.
- Healt Condition(s) or Problem(s) studiedCytokines, Rectal cancer, Chemoradiotherapy
- Inclusion criteria- Age ≥18 - Pathohistological diagnosis of locally advanced rectal adenocarcinoma (<15 cm from the anal verge) - 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) - Planned to undergo a venipuncture for a regular blood collection during preoperative CRT, before, and after surgery - Written informed consent
- Exclusion criteria- Age <18 - Serious adverse events during preoperative chemoradiotherapy - Use of corticosteroids and/or immunosuppressive drugs during or 1 month prior to the study - Other malignancies in medical history - Previous pelvic radiotherapy and/or chemotherapy - Confirmed bacterial or viral infection during the study or 3 months prior to the study
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 27-feb-2014
- planned closingdate1-sep-2015
- Target number of participants30
- InterventionsN/A
- Primary outcomeIdentifying cytokines which can predict response to preoperative chemoradiotherapy in patients with locally advanced rectal cancer.
- Secondary outcomeN/A
- TimepointsWhat: cytokine concentrations Timepoints: 6 blood plasma measurements of cytokines per patient; specifically before, in week 3 and just after preoperative CRT, 1 day before and 2 days and 6 weeks after surgery. Tissue measurements of cytokines will be performed on the resection specimen. How: multiplex immunoassays (LUMINEX)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Lotte Jacobs
- CONTACT for SCIENTIFIC QUERIESDr. M. Los
- Sponsor/Initiator Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Sint Antonius Ziekenhuis Nieuwegein
- Publications
- Brief summaryRationale 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 we want to investigate whether levels of circulating cytokines could predict response to preoperative chemoradiotherapy in patients with rectal cancer. Hypothesis: Our 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 we will collect 4 ml of blood from a selection of rectal cancer patients during a regular venipuncture before, during and after preoperative CRT 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 CRT 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 CRT (oral capecitabine and 45-50 gray (Gy) in total; fractions of 1.8-2 Gy) and surgery. Country of recruitment: The Netherlands
- Main changes (audit trail)
- RECORD26-feb-2014 - 8-apr-2014


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