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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 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. The trial reports 1 study location across 1 state.

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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.

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

FieldValue
Enrollment Target 80 participants
Start Date 2009-11
Est. Completion 2014-09
Phase Phase 2

What the Registry Record Tells You About NCT01060007

The ClinicalTrials.gov registry entry for NCT01060007 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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