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NCT00216424 · ClinicalTrials.gov registry record · Phase 4

Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma

A Phase 4 study, sponsored by James A. Haley Veterans Administration Hospital.

Terminated
Registry status
Phase 4
Development phase
40
Enrollment target

NCT00216424: Clinical Trial Phase 4 study, sponsored by James A. Haley Veterans Administration Hospital.

NCT00216424 is a Phase 4 study that was terminated before completion, run by James A. Haley Veterans Administration Hospital. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00216424, a Phase 4 study, was terminated before completion, sponsored by James A. Haley Veterans Administration Hospital.

TERMINATED
Registry status
Phase 4
Development phase
40 participants
Enrollment target

Study Summary

This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. In addition, it is expected that the simplicity of using an oral agent (capecitabine) will be associated with reduced cost and resource utilization.

Interventions

  • DRUG Capecitabine (Xeloda)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2005-02
Est. Completion 2007-01
Phase Phase 4

Why NCT00216424 stopped before completion

NCT00216424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Capecitabine (Xeloda) is the first listed.

NCT00216424 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00216424 about?

NCT00216424 is a clinical study titled "Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma". This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma ...

What is the current status of trial NCT00216424?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2005-02. Estimated completion is 2007-01.

What interventions are being tested in trial NCT00216424?

The interventions under investigation include: Capecitabine (Xeloda) (DRUG).

Who is sponsoring clinical trial NCT00216424?

This trial is sponsored by James A. Haley Veterans Administration Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00216424's enrollment target sits among peer trials

40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00216424, the US trial registry maintained by the National Library of Medicine. NCT00216424 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.