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NCT00086931 · ClinicalTrials.gov registry record · Phase 1

Oxaliplatin, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Rectum

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 1
Development phase
37
Enrollment target

NCT00086931: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.

NCT00086931 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00086931, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
37 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and capecitabine may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and capecitabine when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for locally advanced cancer of the rectum. NOTE: \*The phase I portion of this trial closed 06/2005. The best dose of oxaliplatin and capecitabine has been determined.

Interventions

  • DRUG oxaliplatin
  • DRUG capecitabine
  • PROCEDURE conventional surgery
  • RADIATION radiation therapy
  • PROCEDURE neoadjuvant therapy

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2003-09
Est. Completion 2010-05
Phase Phase 1
Roswell Park Cancer Institute

365 total trials

What the finished NCT00086931 record still lists

NCT00086931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.

NCT00086931 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00086931 about?

NCT00086931 is a clinical study titled "Oxaliplatin, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Rectum". RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and capecitabine may make tumor cells more sensitive to radi...

What is the current status of trial NCT00086931?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2003-09. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00086931?

The interventions under investigation include: oxaliplatin (DRUG), capecitabine (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION), neoadjuvant therapy (PROCEDURE).

Who is sponsoring clinical trial NCT00086931?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00086931's enrollment target sits among peer trials

37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00086931, the US trial registry maintained by the National Library of Medicine. NCT00086931 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.