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NotableResults first posted: May 1, 2026Primary endpoint revised · Eligibility criteria expanded, about 10 words · Secondary endpoints revised (9) · 2 morev20Show 5 more changesShow less
MinorSecondary endpoints: details revised at 1 of 6 entriesv16
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NotablePrimary endpoint revisedCompletion date: Jun 8, 2022 to Dec 31, 2026 · Secondary endpoints revised (6) · Study sites revised (56)v15Show 3 more changesShow less
NotablePrimary completion date: Jan 2017 to Mar 8, 2020Completion date: Dec 2019 to Jun 8, 2022 · Start date: Jun 2011 to Jun 21, 2011 · Secondary endpoints revised (6)v13Show 3 more changesShow less
NotablePrimary completion date: May 2016 to Jan 2017Trial status: Recruiting to Active, Not Recruiting · Study sites: 59 to 57 · Completion date: Jun 2019 to Dec 2019v12Show 3 more changesShow less
Trial status: Recruiting to Active, Not Recruiting
Study sites: 59 to 57
Completion date: Jun 2019 to Dec 2019
NotablePrimary endpoint revisedEnrollment target: 885 to 920 · Primary completion date: Jul 2016 to May 2016 · Eligibility criteria shortened, about 20 words · 1 morev11Show 4 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Currently the 3-year disease free survival of patients with locally advanced rectal cancer is about 50%. Current standard treatment for patients at high risk of failing locally and/or systemically includes pre-operative long course radiotherapy (5 weeks) in combination with chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has been demonstrated to improve local control, but had no effect on the overall survival. Different studies in patients with rectal cancer studying the effect of adjuvant post operative chemotherapy did not result in an improved survival. This may be due the fact that rectal cancer surgery (TME) is associated with a high complication rate so substantial proportion of patients cannot receive chemotherapy postoperatively. An alternative approach is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor short-course radiotherapy (5 days) is given, as different studies showed local control of the tumor for a long time. During this waiting period the patient is in a good condition to receive an optimal dose of chemotherapy. The investigators hypothesize that with this proposed protocol both the local tumour and possible micrometastases are effectively treated and that this will result in an increased survival. The investigators will compare this with the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional adjuvant chemotherapy.
Trial Details
NCT Number
NCT01558921
Lead Sponsor
University Medical Center Groningen Collaborators: Karolinska University Hospital, Leiden University Medical Center, Uppsala University Hospital, Dutch Cancer Society