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NCT01558921 · ClinicalTrials.gov registry record · Phase 3
Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial
A Phase 3 study of Rectal Cancer, sponsored by University Medical Center Groningen.
- Active
- Registry status
- Phase 3
- Development phase
- 920
- Enrollment target
- 20
- Study locations
NCT01558921 is a Phase 3 study of Rectal Cancer that is active but no longer recruiting, run by University Medical Center Groningen. The registered enrollment target is 920 participants, below the 3,154-participant average among 70 other Rectal Cancer trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT01558921, a Phase 3 study of Rectal Cancer, is active but no longer recruiting, sponsored by University Medical Center Groningen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 920 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER M1 scheme
- OTHER standard long course chemoradiotherapy
Study Locations (20)
Other
- Aalborg Universitetshospital - Aalborg
- Odense Universitetshospital - Odense
- Noordwest Ziekenhuisgroep - Alkmaar
- Amsterdam UMC, location AMC - Amsterdam
- Amsterdam UMC, location VUMC - Amsterdam
- Nki / Avl - Amsterdam
- Onze Lieve Vrouwe Gasthuis - Amsterdam
- Wilhelmina Ziekenhuis - Assen
- Amphia Ziekenhuis - Breda
- Reinier de Graaf Groep - Delft
- Deventer Hospital - Deventer
- Catharina ZIekenhuis - Eindhoven
- Het Groene Hart Ziekenhuis - Gouda
- Martini Ziekenhuis - Groningen
- Universitair Medisch Centrum Groningen - Groningen
- de Tjongerschans - Heerenveen
- Ziekenhuisgroep Twente - Hengelo
- Spaarne Ziekenhuis - Hoofddorp
Missouri
- Siteman Cancer Center, Washington University Medical School - St Louis
PO BOX 30001
- University Medical Center Groningen - Groningen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 920 participants |
| Start Date | 2011-06-21 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01558921
The ClinicalTrials.gov registry entry for NCT01558921 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 920 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,154-participant average among 70 other Rectal Cancer trials with a reported enrollment target (71% lower). The listed sponsor is University Medical Center Groningen, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which M1 scheme is the first listed.
NCT01558921 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Other, Missouri, PO BOX 30001.
Frequently Asked Questions
What is clinical trial NCT01558921 about?
NCT01558921 is a clinical study titled "Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial". 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 n...
What is the current status of trial NCT01558921?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 920 participants. The study started on 2011-06-21. Estimated completion is 2026-12-31.
What conditions does trial NCT01558921 study?
This clinical trial studies the following conditions: Rectal Cancer.
What interventions are being tested in trial NCT01558921?
The interventions under investigation include: M1 scheme (OTHER), standard long course chemoradiotherapy (OTHER).
Who is sponsoring clinical trial NCT01558921?
This trial is sponsored by University Medical Center Groningen, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01558921 being conducted?
This trial has 20 study locations across Missouri, PO BOX 30001. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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