Rectal CancerCYTORECTNCT02077296
The Predictive Value of Cytokines on Response to Preoperative Chemoradiotherapy in Patients With Rectal Cancer
An observational study of Rectal Cancer, run by St. Antonius Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Rectal Cancer
- Keywords
- cytokines, predictive value, preoperative chemoradiotherapy, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Plasma and tissue cytokine levels
Patients will be followed for the duration of preoperative chemoradiotherapy until 6 weeks after surgery
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lotte Jacobs, MD, St. Antonius Hospital
- Investigators
- Maartje Los, MD, PhD, Principal investigator, St. Antonius HospitalNiels Van Lelyveld, MD, PhD, Principal investigator, St. Antonius HospitalG.T. Rijkers, MD, PhD, Prof, Principal investigator, St. Antonius HospitalLotte Jacobs, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077296
- Sponsor's protocol ID
- NL46983.100.13/R13.044
- Acronym
- CYTORECT
- Status last verified
- Sep 2016
- First submitted
- 26 Feb 2014
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Lin CC, Liu CY, Chen MJ, Wang TE, Chu CH, Wang HY, Shih SC, Hsu ML, Hsu TC, Chen YJ. Profiles of circulating endothelial cells and serum cytokines during adjuvant chemoradiation in rectal cancer patients. Clin Transl Oncol. 2013 Oct;15(10):855-60. doi: 10.1007/s12094-013-1004-6. Epub 2013 Feb 12.
PubMed 23401019Tsavaris N, Voutsas IF, Kosmas C, Gritzapis AD, Baxevanis CN. Combined treatment with bevacizumab and standard chemotherapy restores abnormal immune parameters in advanced colorectal cancer patients. Invest New Drugs. 2012 Feb;30(1):395-402. doi: 10.1007/s10637-010-9533-0. Epub 2010 Sep 7.
PubMed 20820907Xynos ID, Karadima ML, Voutsas IF, Amptoulach S, Skopelitis E, Kosmas C, Gritzapis AD, Tsavaris N. Chemotherapy +/- cetuximab modulates peripheral immune responses in metastatic colorectal cancer. Oncology. 2013;84(5):273-83. doi: 10.1159/000343282. Epub 2013 Feb 22.
PubMed 23445638Trikha M, Corringham R, Klein B, Rossi JF. Targeted anti-interleukin-6 monoclonal antibody therapy for cancer: a review of the rationale and clinical evidence. Clin Cancer Res. 2003 Oct 15;9(13):4653-65.
PubMed 14581334Kinoshita T, Ito H, Miki C. Serum interleukin-6 level reflects the tumor proliferative activity in patients with colorectal carcinoma. Cancer. 1999 Jun 15;85(12):2526-31. doi: 10.1002/(sici)1097-0142(19990615)85:123.0.co;2-3.
PubMed 10375098Debucquoy A, Haustermans K, Daemen A, Aydin S, Libbrecht L, Gevaert O, De Moor B, Tejpar S, McBride WH, Penninckx F, Scalliet P, Stroh C, Vlassak S, Sempoux C, Machiels JP. Molecular response to cetuximab and efficacy of preoperative cetuximab-based chemoradiation in rectal cancer. J Clin Oncol. 2009 Jun 10;27(17):2751-7. doi: 10.1200/JCO.2008.18.5033. Epub 2009 Mar 30.
PubMed 19332731
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Cytokines on Response to Preoperative Chemoradiotherapy in Patients With Rectal Cancer
- ClinicalTrials.gov ID
- NCT02077296
- Acronym / sponsor ID
- CYTORECT / NL46983.100.13/R13.044
- Conditions
- Rectal Cancer
- Keywords
- cytokines, predictive value, preoperative chemoradiotherapy, rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma and tissue cytokine levels
Time frame: 20 weeks
Patients will be followed for the duration of preoperative chemoradiotherapy until 6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Background: PubMed 23401019Lin CC, Liu CY, Chen MJ, Wang TE, Chu CH, Wang HY, Shih SC, Hsu ML, Hsu TC, Chen YJ. Profiles of circulating endothelial cells and serum cytokines during adjuvant chemoradiation in rectal cancer patients. Clin Transl Oncol. 2013 Oct;15(10):855-60. doi: 10.1007/s12094-013-1004-6. Epub 2013 Feb 12.
- Background: PubMed 20820907Tsavaris N, Voutsas IF, Kosmas C, Gritzapis AD, Baxevanis CN. Combined treatment with bevacizumab and standard chemotherapy restores abnormal immune parameters in advanced colorectal cancer patients. Invest New Drugs. 2012 Feb;30(1):395-402. doi: 10.1007/s10637-010-9533-0. Epub 2010 Sep 7.
- Background: PubMed 23445638Xynos ID, Karadima ML, Voutsas IF, Amptoulach S, Skopelitis E, Kosmas C, Gritzapis AD, Tsavaris N. Chemotherapy +/- cetuximab modulates peripheral immune responses in metastatic colorectal cancer. Oncology. 2013;84(5):273-83. doi: 10.1159/000343282. Epub 2013 Feb 22.
- Background: PubMed 14581334Trikha M, Corringham R, Klein B, Rossi JF. Targeted anti-interleukin-6 monoclonal antibody therapy for cancer: a review of the rationale and clinical evidence. Clin Cancer Res. 2003 Oct 15;9(13):4653-65.
- Background: PubMed 10375098Kinoshita T, Ito H, Miki C. Serum interleukin-6 level reflects the tumor proliferative activity in patients with colorectal carcinoma. Cancer. 1999 Jun 15;85(12):2526-31. doi: 10.1002/(sici)1097-0142(19990615)85:123.0.co;2-3.
- Background: PubMed 19332731Debucquoy A, Haustermans K, Daemen A, Aydin S, Libbrecht L, Gevaert O, De Moor B, Tejpar S, McBride WH, Penninckx F, Scalliet P, Stroh C, Vlassak S, Sempoux C, Machiels JP. Molecular response to cetuximab and efficacy of preoperative cetuximab-based chemoradiation in rectal cancer. J Clin Oncol. 2009 Jun 10;27(17):2751-7. doi: 10.1200/JCO.2008.18.5033. Epub 2009 Mar 30.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maartje Los, MD, PhD principal investigator
St. Antonius Hospital
Niels Van Lelyveld, MD, PhD principal investigator
St. Antonius Hospital
G.T. Rijkers, MD, PhD, Prof principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and tissue cytokine levels (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02077296, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.