iquid biopsies for personalized cancer therapy of rectal cancer
- Conditions
- C20C19Malignant neoplasm of rectumMalignant neoplasm of rectosigmoid junction
- Registration Number
- DRKS00009882
- Lead Sponsor
- niversitätsklinikum Carl Gustav Carus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 166
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
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocal recurrence-free survival after 5 years
- Secondary Outcome Measures
Name Time Method - disease-free survival after 5 years<br>- metastases-free survival after 5 years<br>- overall survival after 5 years<br>- acute toxicity (clinical examination during treatment)<br>- late toxicity (clinical examination during follow-up care)<br>- response to neoadjuvant radiochemotherapy (rectal carcinoma) (arm 1) or on neoadjuvant short-term radiotherapy (arm 2)