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Multidimensionell studie utformad för att utveckla ett metodologiskt ramverk baserat på MRI-data för att förutsäga patologiskt fullständigt svar (pCR) hos patienter med lokalt avancerad rektalcancer efter neoadjuvant behandling (RESTAGE)

5 november 2026 uppdaterad av: Institut du Cancer de Montpellier - Val d'Aurelle

Rectal cancer presents a significant global health challenge. Despite improvements in clinical outcomes, significant disparities persist across Europe. These differences are explained not only by the heterogeneity of risk factors and screening strategies, but also by variations in diagnostic and therapeutic approaches, which are highly dependent on medical imaging.

Standard treatment for locally advanced rectal cancer based on staging MRI is neoadjuvant treatment (NAT), for tumour downsizing and downstaging, followed by total mesorectal excision. In a significant proportion of cases, radical surgery leads to substantial long-term complications like sexual and urinary dysfunction, fecal incontinence, and impairment in daily activities. Given that up to 42% of patients show complete tumor regression at pathology (i.e. pathological complete response pCR), to avoid unnecessary radical surgery, non-operative management has become an attractive alternative when there are no signs of viable tumour after NAT (i.e. clinical complete response cCR). Such patients are candidates for Watch-and-Wait (W&W), an established active surveillance policy in specialized centers worldwide relying on clinical examination, endoscopy and MRI.

On the other hand, W&W carries a risk of local regrowth (persistence of microscopic residual disease despite apparent cCR). Even in expert hands, assessment of tumor response is not perfect and local regrowth based on current selection methods occurs in ~30% of cases. Although deferred surgery is a successful treatment with no apparent negative impact on local disease control, an increased rate of distant metastases has been recently reported.

Therefore, there is a critical unmet clinical need to detect complete responses after NAT and avoid unnecessary surgery with its associated morbidity and quality of life impairment risks, while also improving sensitivity for residual microscopic disease that will result in local regrowth and associated reduced disease-free survival.

Rectal cancer poses a burden not only on healthcare systems, but also on patient well-being. Patients frequently suffer from feelings of isolation and helplessness when faced with unpredicted disease-related situations, given the common difficulties to access high quality information and communicate with attending physicians. As such, there is a clear need to unburden healthcare facilities from unnecessary hospital visits, while improving patient outcomes, engagement, support and care.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

115

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Preclinical phase: For patients requiring surgery after neoadjuvant chemoradiotherapy, a surgical consultation will be scheduled as part of routine care. The study will be explained, and an information sheet provided. Participation requires signing the informed consent by the patient and the investigating surgeon.

Clinical phase: When a patient requires an MRI as part of their standard care, the study will be presented during the radiology consultation with an information sheet. If the patient agrees to participate, the informed consent form must be signed by the patient and the investigating physician.

Patients may be included in the study at two possible times: during the MRI performed before neoadjuvant treatment (MRI staging), or during the re-evaluation MRI after neoadjuvant treatment (MRI restaging).

Beskrivning

Inclusion Criteria for the preclinical phase :

  • Age ≥18 years old;
  • Have a confirmed diagnosis of locally advanced rectal cancer;
  • Have completed neoadjuvant chemoradiotherapy;
  • Be a candidate for surgical treatment with total mesorectal excision;
  • Be willing and able to provide written informed consent;
  • Affiliation to the French Social Security System.

Inclusion criteria for the clinical phase:

  • Age ≥18 years old;
  • Have a confirmed diagnosis of locally advanced rectal cancer;
  • Require neoadjuvant chemoradiotherapy or have completed neoadjuvant chemoradiotherapy;
  • Requires either surgical treatment or a non-surgical strategy ("Watch-and-Wait") after neoadjuvant chemoradiotherapy;
  • Be willing and able to provide written informed consent;
  • Affiliation to the French Social Security System.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Phase 1 (Preclinical): An ex-vivo analysis of surgical specimens

15 surgical specimens will be collected after surgery following neoadjuvant treatment. They will be imaged using a 3T MRI with advanced sequences, then returned to the pathology department. This ex vivo MRI will not affect sample preparation or preservation. MRI images will be aligned with histological sections using non-linear registration to compare MRI parameters with digital pathology data. This step will help identify MRI biomarkers that differentiate healthy tissue, post-treatment fibrotic tissue, and residual tumor. We will assess whether diffusion MRI and relaxometry measurements can predict pathological outcomes by analyzing parameters such as fractional anisotropy, mean diffusivity, and kurtosis, using surgical pathological information when available
Phase 2 (Clinical): An in-vivo clinical MRI study.

The same advanced sequences will be added to MRIs performed during routine clinical care: the initial staging MRI before neoadjuvant chemoradiotherapy, the restaging MRI after treatment completion, and follow-up MRIs for patients managed with a non-operative Watch-and-Wait strategy. For each patient, we will collect imaging data, demographics, medical history, tumor characteristics, treatment details, pathology reports, and clinical follow-up (endoscopy and MRI). All data will be pseudonymized. The second phase involves developing a computational model to predict response to neoadjuvant therapy. A machine learning tool will be designed to predict complete pathological response based on quantitative MRI, standard clinical MRI, and clinical information
Övrig: questionnaire completion

For all patients, questionnaires will be completed:

  • At the MRI staging if applicable,
  • At the MRI restaging,
  • Every 3 months during the first year; and
  • Every 6 months during the second year.

The following validated questionnaires will be used:

  • EORTC QLQ-C30 (overall quality of life)
  • EORTC QLQ-CR29 (colorectal cancer-specific symptoms)
  • EORTC IN-PATSAT32 (patient satisfaction with care)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
developpement and validation of a methodological framework based on advanced MRI data to predict pathological complete response in patients with locally advanced rectal cancer after neoadjuvant treatment
Tidsram: From the baseline to the end of follow up, assessed up to 27 months

using the area under the ROC curve (AUC) to distinguish pathological complete response (pCR) from residual disease.
From the baseline to the end of follow up, assessed up to 27 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
evaluation of the overall diagnostic performance of the predictive model.
Tidsram: From the baseline to the end of follow up, assessed up to 27 months

The overall diagnostic performance of the model will be evaluated using various indicators: Diagnostic accuracy: defined as the overall proportion of correct classifications, Sensitivity, Specificity, Positive predictive value and Negative predictive value
From the baseline to the end of follow up, assessed up to 27 months
identification and validation of new MRI biomarkers capable of distinguishing residual tumor from benign fibrotic tissue, using ex vivo MRI of surgical specimens with direct correlation to histological data.
Tidsram: From the baseline to the end of follow up, assessed up to 27 months

MRI-histology correlation: statistical correlation between advanced MRI data (derived from ex vivo acquisitions) and the corresponding histological measurements of surgical specimens. Regions of interest (ROIs) defined on ex vivo MRI will be matched with digitized histology. This criterion will validate the new biomarkers.
From the baseline to the end of follow up, assessed up to 27 months
establishment of a rectal MRI database to support this project and future research.
Tidsram: From the baseline to the end of follow up, assessed up to 27 months

Establishment of a data registry: creation of a functional, populated database of rectal cancer cases that is compliant with the FAIR principles (Findable, Accessible, Interoperable, Reusable).
From the baseline to the end of follow up, assessed up to 27 months
assessment of the impact of the disease and therapeutic strategies on patients' quality of life.
Tidsram: From the baseline to the end of follow up, assessed up to 27 months

Quality of life scores: scores obtained from standardized questionnaires collected via a digital application to assess the overall impact of the disease and treatments on patients' lives. These will be analyzed using linear mixed models, comparing the surgical group with the "Watch-and-Wait" group over time.
From the baseline to the end of follow up, assessed up to 27 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Utredare

  • Studierektor: Stephanie NOUGARET, PHD, ICM Co. Ltd.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

1 november 2029

Avslutad studie (Beräknad)

1 november 2029

Studieregistreringsdatum

Först inskickad

2 februari 2026

Först inskickad som uppfyllde QC-kriterierna

9 februari 2026

Första postat (Faktisk)

11 februari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PROICM 2025-07 RES

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

Tidsram för IPD-delning

Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

Kriterier för IPD Sharing Access

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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