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New combo therapy aims to stop head and neck cancer return

NCT ID NCT00875849

Disease control Sponsor: Centre Antoine Lacassagne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tested whether adding the targeted drug cetuximab to standard chemotherapy and radiation could help prevent head and neck cancer from coming back after surgery. The study enrolled 53 patients with certain high-risk features. The main goal was to see how many patients remained cancer-free after two years.

What this could mean

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

Active substance
cetuximab (a targeted antibody), cisplatin (chemotherapy), and radiation therapy
What this could lead to
If successful, this combination could improve the chance of keeping head and neck cancer from returning after surgery.
What could go wrong
This is a small, early-phase trial with only 53 participants. The added drugs may cause more side effects, and it's unclear if the benefits outweigh the risks.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

53 people

The number who actually took part.

Start date

Mar 2008

Finished

Dec 2013

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.

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * Must have undergone complete macroscopic resection * Presence of ≥ 1 of the following poor prognostic factors after complete resection: * Incomplete microscopic resection and N+ * Complete microscopic resection and \> 2 N+ * Vascular and/or lymphatic embolism * At least 2 peripheral nerve invasions * Positive surgical margins and pT4 lesion * No metastases PATIENT CHARACTERISTICS: * WHO performance status 0-2 * ANC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL * Bilirubin \< 1.5 times upper limit of normal (ULN) * Serum creatinine \< 1.25 times ULN and/or creatinine clearance \> 55 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * No serious and disabling cardiac, renal, hepatic, or respiratory failure * No coronary artery disease or myocardial infarction within the past year * No uncontrolled cardiac arrhythmia * Other active and serious diseases allowed at discretion of the investigator * No known severe allergy to cisplatin, cetuximab, or any of their excipients * No other malignant disease diagnosed within the past 5 years except for basal cell carcinoma of the skin or in situ cervical cancer * No psychological, familial, social, or geographic situations that preclude clinical follow up PRIOR CONCURRENT THERAPY: * No prior treatment (except surgery) for this cancer or another head and neck cancer * At least 3 months since prior treatment with an investigational agent

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms hypopharynx squamous cell carcinoma laryngeal squamous cell carcinoma oral cavity squamous cell carcinoma oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck tongue cancer

As listed by the trial registrant

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

Head and neck cancer

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, 06189, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.