Clinical trial · Interventional
Rectal Cancer CTC Trial
Impact of Neoadjuvant Chemoradiotherapy Versus Surgery Alone on Circulating Tumor Cells in Patients With Stage II-III Rectal Cancer and Negative Circumferential Resection Margin: a Multicenter Randomized Clinical Trial
- 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)
This prospective, multi-centre, randomised clinical trial aims to compare the effect of neoadjuvant chemoradiotherapy versus primary surgery on circulating tumor cells (CTCs) in patients with stage II-III rectal cancer without circumferential resection mar-gin involvement. CTCs are considered a promising biomarker for disease dissemination and treatment response. Patients will be randomized to either primary surgical resection with total mesorectal excision or long-course neoadjuvant chemoradiotherapy followed by surgery. Serial blood samples will be collected at predefined time points to assess the presence and dynamics of CTCs. Secondary endpoints include perioperative morbidity and mortality, local recurrence rate, disease-free survival, and overall survival. The results of this study may provide new insights into the prognostic role of CTCs and contribute to optimising treatment strategies for rectal cancer.
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 Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant radiochemotherapy and surgery | Procedure | — | UNRESOLVED |
| Primary Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Primary Surgery
- description
- Procedure: rectal resection with TME (Total Mesorectal Excision)
- interventionNames
- Procedure: Primary Surgery
- type
- EXPERIMENTAL
- label
- Neoadjuvant radiochemotherapy and surgery
- description
- Procedure: rectal resection with TME performed 6-10 weeks after completion of chemoradiotherapy.
- interventionNames
- Procedure: Neoadjuvant radiochemotherapy and surgery
Primary outcomes (10)
- measure
- Circulating Tumor Cells (CTC) Dynamics - neoadjuvant treatment - shape
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed rectal adenocarcinoma within 12 cm from anal verge * Stage II (cT3-4 N0 M0) or stage III (cT1-4 N1-2, M0) * Negative circumferential resection margin on staging MRI * ASA physical status I-III * Signed informed consent Exclusion Criteria: * Tumor infiltration beyond fascia recti propria on MRI * Metastatic disease (stage IV) * Recurrent rectal cancer * Other concurrent malignancies * Emergency surgery required * Contraindication to surgery under general anesthesia
References
Publications (18)
- BACKGROUNDLu CY, Uen YH, Tsai HL, Chuang SC, Hou MF, Wu DC, Juo SH, Lin SR, Wang JY. Molecular detection of persistent postoperative circulating tumour cells in stages II and III colon cancer patients via multiple blood sampling: prognostic significance of detection for early relapse. Br J Cancer. 2011 Mar 29;104(7):1178-84. doi: 10.1038/bjc.2011.40. Epub 2011 Feb 22. PMID 21343933
- BACKGROUNDHinz S, Roder C, Tepel J, Hendricks A, Schafmayer C, Becker T, Kalthoff H. Cytokeratin 20 positive circulating tumor cells are a marker for response after neoadjuvant chemoradiation but not for prognosis in patients with rectal cancer. BMC Cancer. 2015 Dec 16;15:953. doi: 10.1186/s12885-015-1989-z. PMID 26674974
- BACKGROUNDYadav A, Kumar A, Siddiqui MH. Detection of circulating tumour cells in colorectal cancer: Emerging techniques and clinical implications. World J Clin Oncol. 2021 Dec 24;12(12):1169-1181. doi: 10.5306/wjco.v12.i12.1169. PMID 35070736
- BACKGROUNDBurz C, Pop VV, Buiga R, Daniel S, Samasca G, Aldea C, Lupan I. Circulating tumor cells in clinical research and monitoring patients with colorectal cancer. Oncotarget. 2018 May 11;9(36):24561-24571. doi: 10.18632/oncotarget.25337. eCollection 2018 May 11. PMID 29849961
- BACKGROUNDWu J, Li Z, Zou J, Li L, Cui N, Hao T, Yi K, Yang J, Wu Y. A meta-analysis of the value of circulating tumor cells in monitoring postoperative recurrence and metastasis of colorectal cancer. PLoS One. 2022 Sep 19;17(9):e0274282. doi: 10.1371/journal.pone.0274282. eCollection 2022. PMID 36121855
- BACKGROUNDSun W, Li G, Wan J, Zhu J, Shen W, Zhang Z. Circulating tumor cells: A promising marker of predicting tumor response in rectal cancer patients receiving neoadjuvant chemo-radiation therapy. Oncotarget. 2016 Oct 25;7(43):69507-69517. doi: 10.18632/oncotarget.10875. PMID 27486758
- Pan RJ, Hong HJ, Sun J, Yu CR, Liu HS, Li PY, Zheng MH. Detection and Clinical Value of Circulating Tumor Cells as an Assisted Prognostic Marker in Colorectal Cancer Patients. Cancer Manag Res. 2021 Jun 8;13:4567-4578. doi: 10.2147/CMAR.S300554. eCollection 2021.