Selective neoadjuvant therapy in patients with locally advanced rectal cancer: SELREC - an open-label, randomized controlled, multicenter non-inferiority study
Zusammenfassung der Studie
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)
Untersuchte Intervention
Experimental intervention: Total mesorectal excision (TME) without prior (chemo-)radiotherapy.
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Basel
(BASEC)
Sponsor
Sponsor: Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Heidelberg Sponsor's representative in Switzerland: Clarunis - Universitäres Bauchzentrum Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Marco von Strauss und Torney
+41 61 777 75 81
marco.vonstrauss@clutterclarunis.chClarunis - Universitäres Bauchzentrum Basel, St. Claraspital
(BASEC)
Allgemeine Auskünfte
Universittsklinikum Heidelberg, Klinik fr Allgemein-, Viszeral- und Transplantationschirurgie
+49 6221 56 37426
rosa.klotz@med.uni-heidelberg.de(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
17.12.2024
(BASEC)
ICTRP Studien-ID
DRKS00030567 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Selektive neoadjuvante Therapie bei Patienten mit lokal fortgeschrittenem Rektumkarzinom: SELREC - eine offene, randomisiert-kontrollierte, multizentrische Nicht-Unterlegenheitsstudie (BASEC)
Wissenschaftlicher Titel
Selective Neoadjuvant Therapy of Rectal Cancer Patients: SELREC - a randomized controlled, open, multicentre non-inferiority trial - SELREC (ICTRP)
Öffentlicher Titel
Selective Neoadjuvant Therapy of Rectal Cancer Patients: SELREC - a randomized controlled, open, multicentre non-inferiority trial (ICTRP)
Untersuchte Krankheit(en)
C20Malignant neoplasm of rectum
(ICTRP)
Untersuchte Intervention
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)
Studientyp
interventional (ICTRP)
Studiendesign
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
(ICTRP)
Ein-/Ausschlusskriterien
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)
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
31.03.2023 (ICTRP)
Einschluss des ersten Teilnehmers
04.05.2023 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Rosa Klotz, rosa.klotz@med.uni-heidelberg.de, +49 6221 56 37426, Universittsklinikum Heidelberg, Klinik fr Allgemein-, Viszeral- und Transplantationschirurgie (ICTRP)
Sekundäre IDs
S-059/2023 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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)
Weitere Informationen zur Studie
http://drks.de/search/en/trial/DRKS00030567 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar