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NCT01111942 · ClinicalTrials.gov registry record · Early Phase 1

A Pilot Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer

A Early Phase 1 study, sponsored by Southern Illinois University.

Terminated
Registry status
Early Phase 1
Development phase
4
Enrollment target

NCT01111942: Clinical Trial Early Phase 1 study, sponsored by Southern Illinois University.

NCT01111942 is a Early Phase 1 study that was terminated before completion, run by Southern Illinois University. The registered enrollment target is 4 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01111942, a Early Phase 1 study, was terminated before completion, sponsored by Southern Illinois University.

TERMINATED
Registry status
Early Phase 1
Development phase
4 participants
Enrollment target

Study Summary

This is a non-randomized open-label investigator initiated pilot study comparing follow-up therapy of advanced head and neck cancer subjects initially treated with triple induction chemotherapy. Subjects will receive surgical treatment or combined chemoradiation therapy based on the subject's apparent clinical response. Spared use of radiation therapy for selective patients who have a complete response to induction chemotherapy could improve well being of this patient population without compromising survival.

Primary Outcome

To assess the rate of pathologic complete response of subjects (based on analysis of the surgical specimen), in both the primary site as well as the lymph nodes, with resectable stage III-IV squamous cell carcinoma of the oropharynx treated with TPF induction chemotherapy followed by conservation (organ preservation) surgery for clinically complete responders

Interventions

  • OTHER radiation combined with weekly carboplatin
  • PROCEDURE conservation surgery

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2010-02
Est. Completion 2014-01
Phase Early Phase 1
Southern Illinois University

21 total trials

Why NCT01111942 stopped before completion

NCT01111942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which radiation combined with weekly carboplatin is the first listed.

NCT01111942 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01111942 about?

NCT01111942 is a clinical study titled "A Pilot Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer". This is a non-randomized open-label investigator initiated pilot study comparing follow-up therapy of advanced head and neck cancer subjects initially treated with triple induction chemotherapy. Subjects will receive surgical treatment or combined chemoradiation therapy based on the subject's appare...

What is the current status of trial NCT01111942?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2010-02. Estimated completion is 2014-01.

What interventions are being tested in trial NCT01111942?

The interventions under investigation include: radiation combined with weekly carboplatin (OTHER), conservation surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01111942?

This trial is sponsored by Southern Illinois University, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01111942's enrollment target sits among peer trials

4 1921st of 2000 higher than 53 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early 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 NCT01111942, the US trial registry maintained by the National Library of Medicine. NCT01111942 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.