Selective neoadjuvant therapy in patients with locally advanced rectal cancer: SELREC - an open-label, randomized controlled, multicenter non-inferiority study
Descrizione riassuntiva dello studio
Locally advanced rectal cancer (rectal cancer) is typically treated with a combination of radiation and chemotherapy (radiochemotherapy). Subsequently, the tumor is removed via surgery. Several studies have shown that radiation with chemotherapy prior to surgery significantly reduces local tumor recurrence. However, no improvement in long-term survival (5 years after primary treatment) has been demonstrated. Further studies have shown that in selected patients with rectal cancer, which was at least 1 mm from the tissue layer surrounding the rectum on magnetic resonance imaging (MRI), direct surgery (rectal resection with total mesorectal excision, TME as described above) was similarly effective as the therapeutic approach of neoadjuvant radiation with chemotherapy followed by surgery. This is an important finding, as neoadjuvant radiation with chemotherapy can lead to complications compared to surgery alone. Many patients could be spared these complications if surgery alone were as effective as the combination of neoadjuvant radiation and chemotherapy followed by surgery. Currently, we assume that omitting neoadjuvant radiation with chemotherapy only brings advantages for the immediate disease course of the patients. However, it has not yet been sufficiently studied whether forgoing neoadjuvant therapy poses no long-term disadvantages regarding local tumor recurrence. We aim to answer this question with the SELREC study. A total of 1074 patients are planned to be included in this study.
(BASEC)
Intervento studiato
Experimental intervention: Total mesorectal excision (TME) without prior (chemo-)radiotherapy.
(BASEC)
Malattie studiate
Primary adenocarcinoma in the middle or lower third of the rectum, status T1/2 N1 or T3 N0/1 and a circumferential resection margin (CRM) >1 mm, confirmed by imaging using magnetic resonance imaging (MRI)
(BASEC)
− Primary adenocarcinoma of the rectum (<12 cm from the anal verge/confirmed by rectoscopy according to the German S3 guidelines) − Stage T1/2 N1 or T3 N0/1 − CRM >1 mm (confirmed by MRI) − No distant metastases (M0) − Age ≥18 years − Patient's ability to understand the nature and individual consequences of the clinical study − Signed informed consent
(BASEC)
Criteri di esclusione
- Patients who should not receive multimodal therapy for safety reasons − Patients who require neoadjuvant treatment to preserve the sphincter − Previous radiation therapy to the pelvis − Patients with extensive lymph node involvement (N2) or with enlarged lateral lymph nodes − Extramural vascular invasion or tumor deposits − Patients for whom microsatellite instability (MSI) has been tested and whose MSI status is high. − Participation in another interventional study that could influence the intervention and/or the outcomes of this study − Previous diagnosis of a malignant disease other than basal cell carcinoma − Contraindications for MRI (e.g., non-MRI-compatible pacemaker) − Pregnancy or breastfeeding − Any condition that, in the opinion of the study physician, could pose an unacceptable risk to the patient
(BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Sponsor: Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Heidelberg Sponsor's representative in Switzerland: Clarunis - Universitäres Bauchzentrum Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Marco von Strauss und Torney
+41 61 777 75 81
marco.vonstrauss@clutterclarunis.chClarunis - Universitäres Bauchzentrum Basel, St. Claraspital
(BASEC)
Informazioni generali
Universittsklinikum Heidelberg, Klinik fr Allgemein-, Viszeral- und Transplantationschirurgie
+49 6221 56 37426
rosa.klotz@med.uni-heidelberg.de(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
17.12.2024
(BASEC)
ID di studio ICTRP
DRKS00030567 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Selektive neoadjuvante Therapie bei Patienten mit lokal fortgeschrittenem Rektumkarzinom: SELREC - eine offene, randomisiert-kontrollierte, multizentrische Nicht-Unterlegenheitsstudie (BASEC)
Titolo accademico
Selective Neoadjuvant Therapy of Rectal Cancer Patients: SELREC - a randomized controlled, open, multicentre non-inferiority trial - SELREC (ICTRP)
Titolo pubblico
Selective Neoadjuvant Therapy of Rectal Cancer Patients: SELREC - a randomized controlled, open, multicentre non-inferiority trial (ICTRP)
Malattie studiate
C20Malignant neoplasm of rectum
(ICTRP)
Intervento studiato
Group 1: TME (total mesorectal excision): open or minimally-invasive surgery (laparoscopic or robotic) in terms of low anterior resection or abdomino-perineal resection with dissection of the rectum and all pararectal lymph nodes within the mesorectal envelope duration: 3-6h.
Group 2: Guideline-compliant neoadjuvant (chemo)radiotherapy (n(C)RT) according to the German S3-guideline followed by open or minimally-invasive surgery (laparoscopic or robotic) in terms of low anterior resection or abdomino-perineal resection with TME (total mesorectal excision) performed up to twelve weeks after the end of n(C)RT.
(ICTRP)
Tipo di studio
interventional (ICTRP)
Disegno dello studio
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
(ICTRP)
Criteri di inclusione/esclusione
Inclusion criteria: - Primary adenocarcinoma of the rectum <12cm from the anal verge
- T3 and/or N1 disease
- CRM >1mm (MRI based)
- No evidence of distant metastasis (M0)
- Age =18 years
- Ability of patient subject to understand character and individual consequences of the clinical trial
- Written informed consent
(ICTRP)
Exclusion criteria: - Patients who should not receive multimodal treatment for safety reasons
- Patients needing neoadjuvant treatment for sphincter preservation
- Previous radiotherapy to the small pelvis
- Patients with extensive lymph node spread (N2)
- Extramural vascular invasion or tumour deposits
- Participation in another interventional trial with interference of intervention and/or outcome of this trial
- Previous diagnosis of malignant disease within 5 years prior to current disease except basal cell carcinomaa
- Contraindications for MRI (e.g. non-MRI-compatible cardiac pacemaker)
- Pregnancy or lactation
- Any condition that could result in an undue risk for the patient based on the investigators assessment
(ICTRP)
Endpoint primari e secondari
Local recurrence within three years after surgery
(ICTRP)
Major low anterior resection syndrome (LARS), overall survival, disease-free survival, local-recurrence-free survival, distant-metastases-free survival, acute toxicity of (chemo)radiotherapy, perioperative morbidity, perioperative mortality, length of hospital stay, course of tumour markers, quality of life, functional scores (urinary and sexual)
(ICTRP)
Data di registrazione
31.03.2023 (ICTRP)
Inclusione del primo partecipante
04.05.2023 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Rosa Klotz, rosa.klotz@med.uni-heidelberg.de, +49 6221 56 37426, Universittsklinikum Heidelberg, Klinik fr Allgemein-, Viszeral- und Transplantationschirurgie (ICTRP)
ID secondari
S-059/2023 (ICTRP)
Risultati-Dati individuali dei partecipanti
YesAnonymous data will be made publicly available (in an appropriate data repository) for re- and meta-analyses after completion of the trial upon request.
(ICTRP)
Ulteriori informazioni sullo studio
http://drks.de/search/en/trial/DRKS00030567 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile