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The Predictive Value of Cytokines on Response to Preoperative Chemoradiotherapy in Patients With Rectal Cancer

NCT02077296 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2016-09-09

No results posted yet for this study

Summary

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

Conditions

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Maartje Los, MD, PhD · St. Antonius Hospital

  • Niels Van Lelyveld, MD, PhD · St. Antonius Hospital

  • G.T. Rijkers, MD, PhD, Prof · St. Antonius Hospital

  • Lotte Jacobs, MD · St. Antonius Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02077296 on ClinicalTrials.gov