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NCT01525927 · ClinicalTrials.gov registry record · Phase 2

Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity

A Phase 2 study, sponsored by Northwell Health.

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT01525927 is a Phase 2 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 2 participants.

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The verdict

NCT01525927, a Phase 2 study, was terminated before completion, sponsored by Northwell Health.

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study Summary

This study looks at the use of three cycles of chemotherapy given prior to radiation therapy in patients with cancer of the oral cavity and evidence of prior exposure to Human Papilloma Virus (HPV). Patients with cancer of the oral cavity who have evidence of exposure to HPV have a better prognosis than those who do not have such evidence of exposure to HPV. The main hypothesis of this study is that using three cycles of chemotherapy prior to embarking on radiation therapy will allow the use of reduced doses of radiation therapy and, therefore, less radiation induced side-effects. The primary objective is to determine the activity of this pre-radiation chemotherapy strategy along with reduced dose levels of radiation with or without chemotherapy during the radiation phase. The effectiveness of the strategy will be assessed at three months following the completion of the radiation therapy phase and also at two years following completion of the radiation therapy.

Interventions

  • DRUG chemotherapy
  • RADIATION radiotherapy
  • RADIATION Reduced dose radiotherapy

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2010-08
Est. Completion 2011-12
Phase Phase 2

Sponsor

Northwell Health

370 total trials

What the Registry Record Tells You About NCT01525927

The ClinicalTrials.gov registry entry for NCT01525927 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which chemotherapy is the first listed.

NCT01525927 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01525927 about?

NCT01525927 is a clinical study titled "Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity". This study looks at the use of three cycles of chemotherapy given prior to radiation therapy in patients with cancer of the oral cavity and evidence of prior exposure to Human Papilloma Virus (HPV). Patients with cancer of the oral cavity who have evidence of exposure to HPV have a better prognosis ...

What is the current status of trial NCT01525927?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2010-08. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01525927?

The interventions under investigation include: chemotherapy (DRUG), radiotherapy (RADIATION), Reduced dose radiotherapy (RADIATION).

Who is sponsoring clinical trial NCT01525927?

This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.