EICHORCondition: Rectal Cancer · Consolidation · Sponsor: Hospital Alemão Oswaldo Cruz
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Background: Neoadjuvant chemoradiation (nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait - WW). Consolidation chemotherapy (cCT) regimens using fluoropyrimidine-based with or without oxaliplatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCt compared to fluoropyrimidine alone regimens in terms of primary tumor response remains unclear. Since oxaliplatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine+oxaliplatin) for patients with distal rectal cancer. Methods: In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine+oxaliplatin. Magnetic resonance (MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1cm above the anorectal ring determined by sag…
This description comes directly from the study's public registry record.
Rodrigo O Perez, Dr · +551138871757 · roperez@haoc.com.br
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Inclusion Criteria: 1. Age ≥18 years; 2. ECOG 0-2 or KPS≥70; 3. Primary rectal adenocarcinoma (biopsy confirmed) within the reach of digital rectal examination (at least lower tip/border) by the attending colorectal surgeon; 4. Endoscopic documentation; 5. Abdominal and chest CT scans showing no evidence of metastatic disease; 6. High-resolution magnetic resonance images performed at either 1.5T or 3.0T system using a phased array surface coil with: sagittal T2 images including the anal verge and the sacrum; axial oblique T2 weighted images acquired in a plane perpendicular to the long axis of the rectal wall guided by the sagittal images; coronal images acquired in parallel to the anal canal plane. Small field of view (16-18cm), 3mm section thickness, increased matrix size and increased number of signal averages are required; 7. Radiological defining criteria (centralized): 1. Lower edge of tumor at the level (max. 1cm distance) or below the anorectal ring defined at sagittal or coronal views; 2. mrT2, mrT3 (any subclassification) 3. mrN0-1 (≤3 radiologically positive lymph nodes) 4. mrEMVI: any status 5. mrMRF: any status Exclusion Criteria: 1. Pregnancy 2. ECOG ≥3 or KPS\<70 3. Unwilling to consent 4. Metastatic disease (any kind; internal iliac and obturator nodes are considered local disease and not metastatic disease and therefore will not be considered as exclusion criteria) 5. mrT4 or mrN2 6. Previous pelvic irradiation 7. Baseline neuropathy 8. Receiving treatment of other anti-cancer drug or methods 9. Presence of uncontrolled life threatening diseases
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Hospital Italiano de Buenos Aires | Buenos Aires, Argentina | Recruiting |
| Hospital Ramos Mejia: Hospital General de Agudos Dr. Jose Maria Ramos Mejia | Buenos Aires, Argentina | Recruiting |
| Hospital de Gastroenterologia Udaondo Ciudad de Buenos Aires | Buenos Aires, Argentina | Recruiting |
| Hospital Britanico de Buenos Aires - Asociacion Civil | Buenos Aires, Argentina | Recruiting |
| Hospital Curruca: Superintendencia de Bienestar Policia Federal Argentina | Buenos Aires, Argentina | Recruiting |
| Hospital Alemão Oswaldo Cruz | São Paulo, São Paulo, Brazil | Recruiting |
| Hospital Felicio Rocho | Belo Horizonte, Brazil | Recruiting |
| Hospital das Clínicas da Faculdade de Medicina de Botucatu | Botucatu, Brazil | Recruiting |
| Complexo de Saude São João de Deus - Divinopolis | Divinópolis, Brazil | Recruiting |
| Hospital das Clinicas de Passo Fundo | Passo Fundo, Brazil | Recruiting |
| Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre, Brazil | Recruiting |
| Hospital das Clinicas de Porto Alegre | Porto Alegre, Brazil | Recruiting |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05000697