C20 C19
Conditions
Interventions
Group 1: Patients with advanced rectal cancer receiving neoadjuvant chemoradiation. Biomarker analyses of the tumor and blood specimens will be carried out (obligatory)
biomarker analyses of urine specimens are being conducted on a facultative basis.
Group 2: Patients with advanced rectal cancer who receive neoadjuvant short-term radiotherapy. Biomarker analyses of t
biomarker analyses of urine specimens are being conducted on a facultative basis.
Sponsors
Universitätsklinikum Carl Gustav Carus
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Arm 1 - advanced rectal cancer - neoadjuvant radiochemotherapy - cT3 / cT4, cN0 cM0 / 1 or any cN + indep. from T and M Status - paraffin block from the diagnostic biopsy material and from the surgery preparation available in pathology and for scientific investigation - imaging examination before surgery available - surgery report and written histology finding available - performance status WHO 0-2 - tumor volume and location allow curative radiochemotherapy - Age = 18 years Arm 2 - advanced rectal cancer - neoadjuvant radiochemotherapy - prescribed dose: 25 Gy à 5 Gy / fraction - cT3 / cT4, cN0 cM0 / 1 or any cN + indep. from T and M status - paraffin block from the diagnostic biopsy material and from the surgery preparation available in pathology and for scientific investigation - imaging examination before surgery available - surgery report and written histology finding available - performance status WHO 0-2 - Age = 18 years
Exclusion criteria
Exclusion criteria: - other tumor disease that requires therapy or influences probability of survival of the patient - tumor independent diseases or conditions which reduce the probability of survival of the patient to < 2 years - previous irradiation in the pelvic area - pregnancy - lack of understanding or lack of cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local recurrence-free survival after 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| - disease-free survival after 5 years - metastases-free survival after 5 years - overall survival after 5 years - acute toxicity (clinical examination during treatment) - late toxicity (clinical examination during follow-up care) - response to neoadjuvant radiochemotherapy (rectal carcinoma) (arm 1) or on neoadjuvant short-term radiotherapy (arm 2) | — |
Countries
Germany
Contacts
Public ContactAnnett Klöber
Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
Outcome results
None listed