Clinical trial NCT00953511: Cologne Esophageal Response Prediction Study (CERP-Study)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Keywords: esophagus
chemoradiation
excision repair cross-complementing gene
polymorphism
response prediction
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: histopathologic response to chemoradiation
timeFrame: 1 month postoperative
Secondary outcomes:
measure: prognosis
timeFrame: 2 years after surgical resection
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of General, Visceral and Cancer Surgery, University of Cologne
state: NRW
Study officials:
affiliation: Department of General, Visceral and Cancer Surgery, University of Cologne
name: Arnulf H. Hölscher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warnecke-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.
citation: Brabender 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.
citation: Bollschweiler 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.
citation: Schneider 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.
citation: Bollschweiler 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.