Prospective validation of a predictive model for pathologic complete response after chemoradiotherapy in rectal cancer: A prognostic study
Completed
- Conditions
- cancer of the rectum/rectumcancer1000211210017991
- Registration Number
- NL-OMON33076
- Lead Sponsor
- MAASTRO clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
• Histological proven rectal cancer
• UICC stage I-III
• Only primary tumors; no recurrences
• Willing and able to comply with the study prescriptions
• 18 years or older
• Have given written informed consent before patient registration
• No previous radiotherapy to the pelvis
• Only patients treated with concurrent chemoradiation
Exclusion Criteria
• Not adenocarcinoma histology
• History of prior pelvis radiotherapy
• No contra-indication for PET-CT ( claustrofobia/allergy)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Prediction of pathological complete response (ypT0N0) 8-12 weeks after<br /><br>long-series chemoradiotherapy. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Several binary outcomes (assessed from pathology 8-12 weeks after long-series<br /><br>chemoradiotherapy) are predicted for treatment adaptation:<br /><br>1. TRG12 versus TRG34 (TRG: tumor regression grade, see Appendix F)<br /><br>2. TRG1 versus TRG234<br /><br>3. Percentage of ypT1-T2, N0 </p><br>