common.study.topics.clinical

Non-Operative Management for Locally Advanced Rectal Cancer

common.study.values.description

Non-operative Management for Locally Advanced Rectal Cancer

This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Recruiting patients only common.study.methods.is-healthy-yes

Procedure - Non-operative management

Patients who are eligible and provide informed consent to participate in the trial will undergo non-operative management (i.e., active surveillance for 24 months) according to the schedule outlined in the study protocol.

participant.views.study.view.additional

participant.views.study.view.scientific-title

Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer

common.study.values.clinical-trial-id

NCT03179540

participant.views.study.view.id

rb2pKe