Can a daily pill shut down head and neck tumors before surgery?

NCT ID NCT00144976

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers are testing whether erlotinib, a drug that blocks a cancer growth signal, changes head and neck squamous cell tumors when taken before surgery. Participants take a 150 mg pill once a day for 18 to 28 days, then have their planned operation. The study measures whether the drug shuts down the EGFR protein in the tumors and compares drug levels in the blood with the effect on the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
erlotinib, a drug that blocks a cancer growth signal
What this could lead to
If erlotinib blocks the tumor's growth signal as intended, doctors could use it before surgery to help control head and neck cancers.
What could go wrong
This is a small pilot study with 43 people, so any signal may not hold up in larger trials. Erlotinib can cause rash, diarrhea, and other side effects, and it may not affect these tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

43 people

The number who actually took part.

Start date

Oct 2003

Finished

Dec 2006

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Neck and head epidermoid carcinoma histologically proved. Patient with an ENT epidermoid tumor can be included in the study if this relapse is located in an area not irradiated yet. * At least tumor classified T2NXM0 * Patient who can be picked up in a first surgery with a curative purpose or who must have a necessity's surgery (cervical curettage for voluminous adenopathies before radiotherapy) * Patient without clinical or radiological sign of metastatic disease * Good general status (OMS ≤ 2) * Patient able to ingest food. * Age ≥ 18 years * Well-informed written consent, signed by the patient. * Patient with sickness benefit Exclusion Criteria: * Patient with relapse ever treated by radiotherapy * Other prospective study's participation * Recent and massive digestive haemorrhage * Medical contra-indication like main general status alteration, uncontrolled serious infectious disease, main uncontrolled metabolic anomaly ongoing. * Pre-existent pulmonary pathology (BPCO, pleurisy, lymphangitis, interstitial syndrome) * Severe cardiac pathology (stage 3 or 4 cardiac insufficiency, unstable angina pectoris, uncontrolled arrhythmia, myocardium's infarction antecedent during the year that precede the inclusion. * Ophthalmic pathology antecedent concerning the ocular surface or lens-carrier * Concomitant administration, by local or general tract, of drug responsible for ocular drought or which could delay the epithelial cicatrization * Less than 1000 polynuclear neutrophil leucocytes or less than 75000 blood-platelets at inclusion * Bilirubin at higher concentration than one point five times the normal * Renal insufficiency (glomerular filtration flow ≤ 40 ml/min)calculated in accordance with Cockroft's formula * Tacking of Beta blockers, amiodarone, NSAIDs, bleomycin, just before or during the study * Pregnant or nursing women * Patient under guardianship or trusteeship.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Center Oscar Lambret

    Lille, France

  • Institut claudius regaud

    Toulouse, France

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