Clinical trial · Observational
Validation of a Predictive Model After Complete Response in Rectal Cancer
Prospective Validation of a Predictive Model for Pathologic Complete Response After Chemoradiotherapy in Rectal Cancer: A Prognostic Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background of the study: Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in individualizing treatment strategies, i.e., selecting patients who need less invasive surgery or another radiotherapy strategy instead of resection. For rectal cancer it is known that 10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From a retrospective study with multivariate analysis of both clinical and 2-\[18F\] fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that adding FDG-PET data collected before and after CRT leads to a more predictive model compared to evaluating only pretreatment clinical data. To validate this model, this registration study is proposed. Furthermore, it has been found that FDG-PET during treatment is very predictive for response and a more favorable time point to adapt treatment. Also, there are indications that adding blood biomarkers to the data, results in higher accuracy for response prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment and blood sampling are included in the protocol to improve the accuracy of the prediction models. Objective of the study: The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient. Study design: 28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathological complete response (ypT0N0)
- timeFrame
- 8-12 weeks after long-series chemoradiotherapy
Secondary outcomes (1)
- measure
- Several extra outcomes are registered for research: Local relapse at 2 years, metastases free survival, survival and relapse free survival
- timeFrame
- five years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven rectal cancer * UICC stage I-III * Only primary tumors; no recurrences * Only concurrent chemoradiotherapy treatment * 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 Exclusion Criteria: * No adenocarcinoma histology * History of prior pelvis radiotherapy
References
Publications (1)
- DERIVEDRoelofs E, Dekker A, Meldolesi E, van Stiphout RGPM, Valentini V, Lambin P. International data-sharing for radiotherapy research: an open-source based infrastructure for multicentric clinical data mining. Radiother Oncol. 2014 Feb;110(2):370-374. doi: 10.1016/j.radonc.2013.11.001. Epub 2013 Dec 3. PMID 24309199