Re-irradiation plus cetuximab targets head and neck tumors that return
NCT ID NCT00738868
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether combining cetuximab, a drug that blocks tumor growth, with stereotactic body radiation therapy can help patients whose head and neck cancer has returned after earlier radiation and cannot be removed by surgery. The trial enrolls about 45 people with recurrent squamous cell carcinoma of the head and neck and no metastatic disease. The main goal is to see how many patients have nonprogressive disease at 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cetuximab combined with stereotactic body radiation therapy
- What this could lead to
- If it works, this combination could offer a way to control recurrent head and neck cancer that has come back after prior radiation and cannot be removed by surgery.
- What could go wrong
- This is a small phase 2 trial, so any benefit seen may not hold up in larger studies. Re-irradiation carries a risk of damaging normal tissue in an area that has already received radiation.
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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
-
About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
-
Oct 2007
- 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 to 120 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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 head and neck * Unresectable disease * Recurrent disease * No metastatic disease * Disease in previously irradiated area must be proven by biopsy or imaging * At least 3 months between prior radiotherapy and diagnosis of recurrent disease * Surgery or brachytherapy must be possible * Measurable or evaluable disease by RECIST criteria * No available curative therapy PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Not pregnant or nursing * No psychological, familial, social, or geographical reasons that would make monitoring the patient impossible * No other malignant disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent participation in another clinical study of an experimental drug
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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
-
Centre Oscar Lambret
Lille, 59020, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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