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NCT01283178 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC

A Phase 1 study, sponsored by Virginia Commonwealth University.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT01283178: Clinical Trial Phase 1 study, sponsored by Virginia Commonwealth University.

NCT01283178 is a Phase 1 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01283178, a Phase 1 study, was terminated before completion, sponsored by Virginia Commonwealth University.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer

Interventions

  • DRUG cisplatin
  • RADIATION intensity-modulated radiation therapy
  • PROCEDURE positron emission tomography/computed tomography
  • OTHER 3'-deoxy-3'-[18F]fluorothymidine
  • RADIATION image-guided adaptive radiation therapy

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2011-07
Est. Completion 2016-09
Phase Phase 1
Virginia Commonwealth University

558 total trials

Why NCT01283178 stopped before completion

NCT01283178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

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

NCT01283178 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01283178 about?

NCT01283178 is a clinical study titled "Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC". RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. Drugs used in chemotherapy, such as cisplati...

What is the current status of trial NCT01283178?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2011-07. Estimated completion is 2016-09.

What interventions are being tested in trial NCT01283178?

The interventions under investigation include: cisplatin (DRUG), intensity-modulated radiation therapy (RADIATION), positron emission tomography/computed tomography (PROCEDURE), 3'-deoxy-3'-[18F]fluorothymidine (OTHER), image-guided adaptive radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT01283178?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01283178's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 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 NCT01283178, the US trial registry maintained by the National Library of Medicine. NCT01283178 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.