SCARLET - Italian proSpeCtionAl obseRvationaL multicEntre Study on Treatment for recTal pT1 Cancer (SCARLET)
Aperçu de l'étude
Statut
Description détaillée
Background To date, the therapeutic management of patients with pathological T1 (pT1) rectal cancer after local surgical or endoscopic excision remains a subject of ongoing debate. Although traditional radical surgery has demonstrated proven advantages, discussion persists regarding the adequacy of less invasive techniques for specific subgroups of patients, particularly those with a low risk of disease progression. In these cases, local excision options through endoscopic or surgical interventions, including Endoscopic Submucosal Dissection (ESD), Transanal Minimally Invasive Surgery (TAMIS), and Transanal Endoscopic Microsurgery (TEM), may represent a valid curative approach. These techniques, which generally carry a low risk of lymph node metastasis, offer important advantages in terms of organ preservation and reduction of postoperative complications, including anorectal, urinary, and sexual dysfunction, which may significantly impair quality of life.
Rationale The choice of a conservative approach must be carefully evaluated, especially when post-excision histopathological analysis reveals high-risk features. These include deep submucosal invasion greater than 1 mm, poor tumor differentiation, tumor budding, lymphovascular invasion, or positive or close resection margins. In these situations, radical surgery with Total Mesorectal Excision (TME) is considered the standard treatment strategy for reducing the risk of local and nodal recurrence, although available evidence is largely derived from retrospective studies. Because TME may substantially affect quality of life and functional outcomes, treatment decisions should be discussed within a multidisciplinary team. National and international guidelines suggest that patients with pT1 rectal cancer who present high-risk features and are either unwilling or unsuitable to undergo radical surgery may be considered for alternative organ-preserving strategies, including adjuvant radiotherapy or chemoradiotherapy.
Study Objective This prospective, observational, multicenter study aims to evaluate the impact of adjuvant radiotherapy or chemoradiotherapy on Disease-Free Survival (DFS) in patients with pT1 rectal cancer presenting at least one high-risk histopathological feature who have undergone local excision and declined treatment with TME. The study will also assess long-term oncologic outcomes, organ preservation, and quality of life in this patient population.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Giuditta Chiloiro, MD, Phd
- Numéro de téléphone: 06-30154981
- E-mail: giuditta.chiloiro@policlinicogemelli.it
Lieux d'étude
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RM
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Roma, RM, Italie, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Contact:
- Giuditta Chiloiro, MD, Phd
- Numéro de téléphone: 06-30154981
- E-mail: giuditta.chiloiro@policlinicogemelli.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age 18 years or older.
- Good performance status (Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1).
- Primary tumor of the distal rectum (clinical T1) amenable to local endoscopic resection using Endoscopic Submucosal Dissection (ESD) or local surgical resection using Transanal Endoscopic Microsurgery (TEM) or Transanal Minimally Invasive Surgery (TAMIS).
High-risk pathological T1 rectal cancer meeting at least one of the following conditions:
i) Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma.
ii) Pathological submucosal invasion greater than 1000 micrometers. iii) Positive lymphatic invasion or positive venous invasion confirmed by immunohistochemistry.
iv) Tumor budding grade 2 or 3. v) Positive lateral or vertical resection margin (tumor within 1 mm of the surgical margin) or non-assessable resection margin.
- No lymph node or distant metastases confirmed by computed tomography of the chest, abdomen, and pelvis (clinical N0, M0 disease).
- Radiotherapy or chemoradiotherapy initiated within 12 weeks after local endoscopic or surgical resection.
- No previous rectal resection (other than local excision) or pelvic irradiation for any malignancy.
- Adequate organ function as assessed by the treating physician.
- The treating surgeons have explained to the patient that the current standard of care is Total Mesorectal Excision (TME) with D2 lymph node dissection and the patient has declined this treatment.
- Candidate for adjuvant chemoradiotherapy according to routine clinical practice.
- Written informed consent provided.
Exclusion Criteria:
- Synchronous or metachronous malignancy diagnosed within the previous 5 years.
- Infection requiring systemic treatment.
- Requirement for continuous systemic treatment with corticosteroids or immunosuppressive agents.
- Diagnosis of a hereditary colorectal cancer syndrome, including familial adenomatous polyposis or Lynch syndrome, or diagnosis of inflammatory bowel disease, including ulcerative colitis or Crohn disease.
- Squamous cell carcinoma, neuroendocrine neoplasm, or mixed neuroendocrine-non-neuroendocrine neoplasm histology.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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3-year Disease-Free Survival (DFS)
Délai: 3-years
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Percentage of patients who remain alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at three years from the start of follow-up.
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3-years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Disease-free survival at 1 year
Délai: 1 year
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Percentage of patients alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at 1 year from follow-up.
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1 year
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Disease-free survival at 5 years
Délai: 5 years
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Percentage of patients alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at 5 years from follow-up.
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5 years
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Local recurrence-free survival at 1 year
Délai: 1 year
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Time from the end of treatment to the documentation of local disease recurrence at 1 year.
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1 year
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Local recurrence-free survival at 3 years
Délai: 3 years
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Time from the end of treatment to the documentation of local disease recurrence at 3 years.
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3 years
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Local recurrence-free survival at 5 years
Délai: 5 years
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Time from the end of treatment to the documentation of local disease recurrence at 5 years.
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5 years
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Overall survival at 1 year
Délai: 1 year
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Percentage of patients alive at 1 year from the start of follow-up.
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1 year
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Overall survival at 3 years
Délai: 3 years
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Percentage of patients alive at 3 years from the start of follow-up.
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3 years
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Overall survival at 5 years
Délai: 5 years
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Percentage of patients alive at 5 years from the start of follow-up.
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5 years
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Colostomy-free survival at 1 year
Délai: 1 year
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Percentage of patients alive without the need for a temporary or permanent stoma/colostomy at 1 year.
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1 year
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Colostomy-free survival at 3 years
Délai: 3 years
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Percentage of patients alive without the need for a temporary or permanent stoma/colostomy at 3 years.
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3 years
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Quality of life assessed by EORTC QLQ-C30 Global Health Status/Quality of Life score at 1 year
Délai: 1 year
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Patient-reported quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
The Global Health Status/Quality of Life score ranges from 0 to 100 after linear transformation.
Higher scores indicate better quality of life.
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1 year
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Colorectal cancer-specific quality of life assessed by EORTC QLQ-CR29 at 1 year
Délai: 1 year
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Patient-reported colorectal cancer-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Colorectal Cancer Questionnaire (EORTC QLQ-CR29).
Questionnaire scores are transformed to a 0-100 scale.
For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden.
Individual QLQ-CR29 scale scores will be analyzed separately.
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1 year
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Quality of life assessed by EORTC QLQ-C30 Global Health Status/Quality of Life score at 3 years
Délai: 3 years
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Patient-reported quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
The Global Health Status/Quality of Life score ranges from 0 to 100 after linear transformation.
Higher scores indicate better quality of life.
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3 years
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Colorectal cancer-specific quality of life assessed by EORTC QLQ-CR29 at 3 years
Délai: 3 years
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Patient-reported colorectal cancer-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Colorectal Cancer Questionnaire (EORTC QLQ-CR29).
Questionnaire scores are transformed to a 0-100 scale.
For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden.
Individual QLQ-CR29 scale scores will be analyzed separately.
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3 years
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Acute toxicity within 6 months from treatment
Délai: Within 6 months from the end of treatment
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Incidence and severity of acute adverse events (genitourinary, gastrointestinal, and hematologic) scored according to CTCAE version 5.0.
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Within 6 months from the end of treatment
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Late toxicity at 2 years after the end of treatment
Délai: 2 years after the end of treatment
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Incidence and severity of long-term treatment-related toxicities scored according to CTCAE version 5.0.
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2 years after the end of treatment
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Nodal Recurrence Rate
Délai: Up to 5 years after completion of adjuvant treatment.
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ercentage of patients who develop regional lymph node recurrence during the follow-up period, as assessed by imaging modalities.
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Up to 5 years after completion of adjuvant treatment.
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Distant Metastases Rate
Délai: Up to 5 years after completion of adjuvant treatment.
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Percentage of patients who develop distant organ metastases (outside the pelvis) during the follow-up period, confirmed by contrast-enhanced chest-abdomen-pelvis CT scan.
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Up to 5 years after completion of adjuvant treatment.
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Giuditta Chiloiro, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 27321
Informations sur les médicaments et les dispositifs, documents d'étude
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