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NCT00408694 · ClinicalTrials.gov registry record · Phase 2

Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
46
Enrollment target

NCT00408694: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00408694 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00408694, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
46 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells.

Primary Outcome

Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Interventions

  • DRUG Cisplatin
  • DRUG Fluorouracil
  • RADIATION Intensity-Modulated Radiation Therapy
  • BIOLOGICAL Bevacizumab
  • RADIATION 3-Dimensional Conformal Radiation Therapy

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2006-12-13
Est. Completion 2011-12-15
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00408694 record still lists

NCT00408694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).

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

NCT00408694 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00408694 about?

NCT00408694 is a clinical study titled "Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer". This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in differen...

What is the current status of trial NCT00408694?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2006-12-13. Estimated completion is 2011-12-15.

What interventions are being tested in trial NCT00408694?

The interventions under investigation include: Cisplatin (DRUG), Fluorouracil (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Bevacizumab (BIOLOGICAL), 3-Dimensional Conformal Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT00408694?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00408694's enrollment target sits among peer trials

46 1286th of 2000 higher than 705 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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Source: ClinicalTrials.gov NCT00408694, the US trial registry maintained by the National Library of Medicine. NCT00408694 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.