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

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ClinicalTrials.gov Identifier: NCT02077296
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Lotte Jacobs, MD, St. Antonius Hospital

Brief 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


Condition or disease
Rectal Cancer

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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).



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Netherlands
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Sponsors and Collaborators
St. Antonius Hospital
Investigators
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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:

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Responsible Party: Lotte Jacobs, MD, MD, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT02077296     History of Changes
Other Study ID Numbers: NL46983.100.13/R13.044
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Lotte Jacobs, MD, St. Antonius Hospital:
cytokines
predictive value
preoperative chemoradiotherapy
rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases