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

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

Trial Details

NCT ID
NCT05000697
Phase
NA
Sponsor
Hospital Alemão Oswaldo Cruz
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Oxaliplatin
  • 5FU
Locations (sample)
  • Buenos Aires, Argentina|-34.61315,-58.37723
  • Buenos Aires, Argentina|-34.61315,-58.37723
  • Buenos Aires, Argentina|-34.61315,-58.37723
  • Buenos Aires, Argentina|-34.61315,-58.37723
  • Buenos Aires, Argentina|-34.61315,-58.37723

Key Eligibility Criteria

  • Age ≥18 years;
  • ECOG 0-2 or KPS≥70;
  • Primary rectal adenocarcinoma (biopsy confirmed) within the reach of digital rectal examination (at least lower tip/border) by the attending colore…
  • Endoscopic documentation;

For full eligibility, visit ClinicalTrials.gov.

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