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NCT02031250 · ClinicalTrials.gov registry record · Phase 2

Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer

A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
Phase 2
Development phase
106
Enrollment target

NCT02031250: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.

NCT02031250 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02031250, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
106 participants
Enrollment target

Study Summary

This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.

Primary Outcome

Kaplan-Meier curves with point-wise 90% confidence intervals will be generated for each treatment arm, overall and by strata. Estimates with confidence intervals will be generated from these curves for the usual summary statistics, including median DFS times.

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • RADIATION IMRT (Intensity-Modulated Radiation Therapy)
  • RADIATION Boost Radiation to Hypoperfused Volumes

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2014-02
Est. Completion 2023-02-22
Phase Phase 2

What the finished NCT02031250 record still lists

NCT02031250 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).

The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.

NCT02031250 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02031250 about?

NCT02031250 is a clinical study titled "Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer". This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging)....

What is the current status of trial NCT02031250?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2014-02. Estimated completion is 2023-02-22.

What interventions are being tested in trial NCT02031250?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), IMRT (Intensity-Modulated Radiation Therapy) (RADIATION), Boost Radiation to Hypoperfused Volumes (RADIATION).

Who is sponsoring clinical trial NCT02031250?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02031250's enrollment target sits among peer trials

106 648th of 2000 higher than 1,351 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 NCT02031250, the US trial registry maintained by the National Library of Medicine. NCT02031250 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.