Clinical trial · Observational
The Predictive Value of Cytokines on Response to Preoperative Chemoradiotherapy in Patients With Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Preoperative chemoradiotherapy
- description
- 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 outcomes (1)
- measure
- Plasma and tissue cytokine levels
- timeFrame
- 20 weeks
- description
- Patients will be followed for the duration of preoperative chemoradiotherapy until 6 weeks after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDLin 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. PMID 23401019
- BACKGROUNDTsavaris 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. PMID 20820907
- BACKGROUNDXynos 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. PMID 23445638
- BACKGROUNDTrikha 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. PMID 14581334
- BACKGROUNDKinoshita 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. PMID 10375098
- BACKGROUNDDebucquoy 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. PMID 19332731