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NCT01588431 · ClinicalTrials.gov registry record · Phase 2

Bevacizumab/Ph 2 for Locally Advanced Head and Neck Cancer

A Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.

Completed
Registry status
Phase 2
Development phase
3
Enrollment target

NCT01588431: Completed Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.

NCT01588431 is a Phase 2 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01588431, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.

COMPLETED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

Locally advanced squamous cell carcinoma of the head and neck (SCCHN) is treated with various combinations of radiation and chemotherapy. This study aims to evaluate the rate of complete responses with induction therapy (primary endpoint) and progression-free survival, overall survival and objective response rates of docetaxel, cisplatin, cetuximab, and bevacizumab (TPE-A) followed by radiation therapy, cisplatin, cetuximab, and bevacizumab (XPE-A). Also, the investigators plan to investigate a panel of EGFR and angiogenesis biomarkers in pre-and post- treatment tumor biopsies. Finally, the investigators will evaluate the associated treatment toxicities and the quality of life.

Primary Outcome

Evaluate the rate of complete responses with induction therapy - Change in baseline regarding treatment/tumor response after 3 cycles of chemotherapy (3months); After 8 weeks of chemo + radiation; 1 year up to 10 years. This outcome will be measured with regards to number of participants via RECIST criteria.

Interventions

  • DRUG Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2011-12
Est. Completion 2022-10-04
Phase Phase 2

What the finished NCT01588431 record still lists

NCT01588431 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery is the first listed.

NCT01588431 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01588431 about?

NCT01588431 is a clinical study titled "Bevacizumab/Ph 2 for Locally Advanced Head and Neck Cancer". Locally advanced squamous cell carcinoma of the head and neck (SCCHN) is treated with various combinations of radiation and chemotherapy. This study aims to evaluate the rate of complete responses with induction therapy (primary endpoint) and progression-free survival, overall survival and objective...

What is the current status of trial NCT01588431?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2011-12. Estimated completion is 2022-10-04.

What interventions are being tested in trial NCT01588431?

The interventions under investigation include: Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery (DRUG).

Who is sponsoring clinical trial NCT01588431?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01588431's enrollment target sits among peer trials

3 2001st of 2000 the lowest 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 NCT01588431, the US trial registry maintained by the National Library of Medicine. NCT01588431 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.