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

September 8, 2016 updated by: Lotte Jacobs, MD, St. Antonius Hospital

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St. Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer diagnosed in St. Antonius Hospital Nieuwegein and Utrecht, 18 years or older, selected for preoperative chemoradiotherapy (chemotherapy: oral capecitabine; radiotherapy: 45-50 Gy in total; fractions of 1.8-2 Gy) and surgery. Rectal carcinoma is defined as <15 cm from the anal verge. They are already routinely planned to undergo a regular venipuncture for blood collection and intravenous needle before surgery.

Description

Inclusion Criteria:

  • 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 chemoradiotherapy, before, and after surgery
  • Written informed consent
  • Age ≥18

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preoperative chemoradiotherapy
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma and tissue cytokine levels
Time Frame: 20 weeks
Patients will be followed for the duration of preoperative chemoradiotherapy until 6 weeks after surgery
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL46983.100.13/R13.044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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