Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy.
Daniela RegaVincenza GranataAntonella PetrilloUgo PaceCinzia SassaroliMassimiliano Di MarzoCarmela CervoneRoberta FuscoValeria D'AlessioGuglielmo NastiCarmela RomanoAntonio AvalloneBiagio PecoriGerardo BottiFabiana TatangeloPiera MaiolinoPaolo DelrioPublished in: Cancers (2021)
This is a Phase II randomized controlled trial enrolling 70 patients that will be developed in two stages. In the first step, 28 patients will be enrolled: 14 of these will receive ECT for four weeks after neo-adjuvant treatment and then local excision (treatment group) and 14 patients will receive neo-adjuvant treatment and then local excision (control group). If an increase of response rate is observed in the first stage, and/or feasibility/safety is demonstrated, the second stage of the trial will be performed, enrolling an additional 42 patients. The treatment response. in both the control arm and the treatment arm, will be assessed using the histopathological tumor regression grade on tissue specimens after local excision.