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Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial
NCT01558921 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 920 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Medical Center Groningen, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01558921 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, Missouri, PO BOX 30001. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01558921?
The interventions under investigation include: M1 scheme (OTHER), standard long course chemoradiotherapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01558921?
This trial is sponsored by University Medical Center Groningen, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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