Clinical trial · Interventional
Cologne Esophageal Response Prediction Study (CERP-Study)
Prospective Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of ERCC1 in Response to Treatment With Neoadjuvant Radiochemotherapy in Patients With Esophageal 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: The prognosis of patients with advanced esophageal cancer may be improved by preoperative chemoradiation. But only those patients have a benefit from this additional therapy, whose tumor shows a response after chemoradiation. Molecular markers may help to identify before starting the therapy those patients who response. PURPOSE: This is the first prospective, clinical trial to study the impact of ERCC1 to predict histopathological response to neoadjuvant radiochemotherapy (RTx/CTx) in patients with cancer of the esophagus.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERCC1 pathways analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- genetic
- interventionNames
- Genetic: ERCC1 pathways analysis
Primary outcomes (1)
- measure
- histopathologic response to chemoradiation
- timeFrame
- 1 month postoperative
- description
- Patients with cT3 esophageal cancer received RTx/CTx according a standardized protocol. 6 weeks after this neoadjuvant therapy a tranthoracic esophagectomy with two-field lymphadenectomy will be performed. The histopathologic response is measured using the surgical specimen.
Secondary outcomes (1)
- measure
- prognosis
- timeFrame
- 2 years after surgical resection
- description
- All patients get a standardized follow-up every three month evaluating clinical signs of response. If necessary additional diagnostic procedures will be performed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * informed consent * newly diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus or cardia Exclusion Criteria: * missing informed consent * prior radiation or chemotherapy * second malignancy
References
Publications (5)
- BACKGROUNDWarnecke-Eberz U, Vallbohmer D, Alakus H, Kutting F, Lurje G, Bollschweiler E, Wienand-Dorweiler A, Drebber U, Holscher AH, Metzger R. ERCC1 and XRCC1 gene polymorphisms predict response to neoadjuvant radiochemotherapy in esophageal cancer. J Gastrointest Surg. 2009 Aug;13(8):1411-21. doi: 10.1007/s11605-009-0881-z. Epub 2009 May 7. PMID 19421825
- BACKGROUNDBrabender J, Vallbohmer D, Grimminger P, Hoffmann AC, Ling F, Lurje G, Bollschweiler E, Schneider PM, Holscher AH, Metzger R. ERCC1 RNA expression in peripheral blood predicts minor histopathological response to neoadjuvant radio-chemotherapy in patients with locally advanced cancer of the esophagus. J Gastrointest Surg. 2008 Nov;12(11):1815-21. doi: 10.1007/s11605-008-0668-7. Epub 2008 Sep 3. PMID 18769985
- BACKGROUNDBollschweiler E, Metzger R, Drebber U, Baldus S, Vallbohmer D, Kocher M, Holscher AH. Histological type of esophageal cancer might affect response to neo-adjuvant radiochemotherapy and subsequent prognosis. Ann Oncol. 2009 Feb;20(2):231-8. doi: 10.1093/annonc/mdn622. Epub 2008 Oct 3. PMID 18836090
- BACKGROUNDSchneider PM, Baldus SE, Metzger R, Kocher M, Bongartz R, Bollschweiler E, Schaefer H, Thiele J, Dienes HP, Mueller RP, Hoelscher AH. Histomorphologic tumor regression and lymph node metastases determine prognosis following neoadjuvant radiochemotherapy for esophageal cancer: implications for response classification. Ann Surg. 2005 Nov;242(5):684-92. doi: 10.1097/01.sla.0000186170.38348.7b. PMID 16244542
- RESULTBollschweiler E, Holscher AH, Herbold T, Metzger R, Alakus H, Schmidt H, Drebber U, Warnecke-Eberz U. Molecular Markers for the Prediction of Minor Response to Neoadjuvant Chemoradiation in Esophageal Cancer: Results of the Prospective Cologne Esophageal Response Prediction (CERP) Study. Ann Surg. 2016 Nov;264(5):839-846. doi: 10.1097/SLA.0000000000001911. PMID 27741011