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NCT01060007 · ClinicalTrials.gov registry record · Phase 2
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
A Phase 2 study of Rectal Neoplasms, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT01060007: Completed Phase 2 study of Rectal Neoplasms, sponsored by Washington University School of Medicine.
NCT01060007 is a Phase 2 study of Rectal Neoplasms that has completed, run by Washington University School of Medicine. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01060007, a Phase 2 study of Rectal Neoplasms, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.
Primary Outcome
T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG 5-FU
- RADIATION External beam radiation
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01060007 record still lists
NCT01060007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Rectal Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT01060007 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT01060007 about?
NCT01060007 is a clinical study titled "Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer". To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.
What is the current status of trial NCT01060007?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2009-11. Estimated completion is 2014-09.
What conditions does trial NCT01060007 study?
This clinical trial studies the following conditions: Rectal Neoplasms.
What interventions are being tested in trial NCT01060007?
The interventions under investigation include: Capecitabine (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), 5-FU (DRUG), External beam radiation (RADIATION).
Who is sponsoring clinical trial NCT01060007?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01060007 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01060007's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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