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Chemoradiation and Consolidation Chemotherapy With or Without Oxaliplatin for Distal Rectal Cancer and Watch and Wait

RecruitingNAAges 18 Years - anyAllHospital Alemão Oswaldo Cruz
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In plain words

What the trial is, and whether it could suit you

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 compar

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📋 Eligibility rules (as published)
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
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What it tests

  • Oxaliplatin
  • 5FU
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Where

24 sites
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Ramos Mejia: Hospital General de Agudos Dr. Jose Maria Ramos Mejia
Buenos Aires, Argentina
Hospital de Gastroenterologia Udaondo Ciudad de Buenos Aires
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires - Asociacion Civil
Buenos Aires, Argentina
Hospital Curruca: Superintendencia de Bienestar Policia Federal Argentina
Buenos Aires, Argentina
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
Hospital Felicio Rocho
Belo Horizonte, Brazil
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, Brazil

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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