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The value of CTPET scans for the prediction of response after treatment in rectal cancer.


- candidate number6884
- NTR NumberNTR2166
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2010
- Secondary IDs 
- Public TitleThe value of CTPET scans for the prediction of response after treatment in rectal cancer.
- Scientific TitleEvaluation of CTPET imaging in the prediction of pathologic complete response after chemoradiotherapy in locally advanced rectal cancer.
- ACRONYM
- hypothesisA model based on the combination of clinical prognostic factors and features extracted from tumor contours from CTPET has a high accuracy to predict pathologic complete response after chemoradiotherapy in locally advanced rectal cancer.
- Healt Condition(s) or Problem(s) studiedRectal cancer, Chemotherapy, PET scan, Prediction
- Inclusion criteria1. Histological proven rectal cancer;
2. Only primary tumors; no recurrences;
3. Only concurrent chemoradiotherapy treatment;
4. 18 years or older.
- Exclusion criteria1. No adenocarcinoma histology;
2. History of prior pelvis radiotherapy.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2004
- planned closingdate1-jan-2014
- Target number of participants500
- Interventions1. FDG-PET imaging (pretreatment);
2. Blood sampling (facultative);
3. FDG-PET imaging (posttreatment, facultative).
- Primary outcomePathologic complete response, defined by ypT0N0 stage extracted from pathologic reports.
- Secondary outcome1. Local control;
2. Distant metastases;
3. Survival;
4. Relapse free survival;
5. Metastases free survival.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. Ruud Stiphout, van
- CONTACT for SCIENTIFIC QUERIESMSc. Ruud Stiphout, van
- Sponsor/Initiator Maastro Clinic
- Funding
(Source(s) of Monetary or Material Support)
Maastro Clinic
- PublicationsN/A
- Brief summaryAccurate prediction of pathologic complete response can help in the selection of patients for optimized treatment, sphincter-preserving surgery, less extensive resection, planning of extra radiation boosts, or even delayed surgery with a wait-and-see policy. Therefore it is valuable to develop an accurate, data-driven model to predict pathologic complete response for rectal cancer patients in order to individualize treatment. CTPET-imaging is known to have predictive value for response in rectal cancer from univariate analyses. In this study CTPET imaging is combined with clinical prognostic factors to develop models and corresponding nomograms to predict response sufficiently accurate to use in trials and in the clinic.
- Main changes (audit trail)
- RECORD14-jan-2010 - 26-jan-2010


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