Could adding chemo to precision radiation boost survival in head and neck cancer?
NCT ID NCT03070366
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial compares stereotactic radiotherapy alone versus radiotherapy plus chemotherapy for people with head and neck cancer that has spread to 1-3 other spots in the body. The main goal is to see if the combination helps patients live at least one year without a drop in quality of life. About 78 adults with good performance status are being studied, and researchers are also looking at side effects and cost-effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chemotherapy (cisplatin, 5FU, carboplatin, or cetuximab) plus stereotactic radiotherapy
- What this could lead to
- If successful, this could show that adding chemotherapy to targeted radiation helps people with head and neck cancer that has spread to a few spots live longer with better quality of life.
- What could go wrong
- This is a mid-stage trial with only 78 participants, so results may not apply to everyone. Chemotherapy can cause significant side effects, and the benefit over radiation alone is not yet proven.
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
-
About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2015
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 77 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age ≥ 18 years * PS:0-2 * Estimated life expectancy ≥ 6 months * Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck * Target metastases can be treated in stereotactic radiotherapy * 1-3 synchronized metastases with unrestricted anatomic site * Greater cumulative diameter of synchronous metastases in once organ (liver, lung or brain) ≤ 6 cm with GTV = Clinical Target Volume (CTV) * Global maximum diameter (GTV) allowed for pulmonary oligometastases (less than 2 cm from the mediastinum), brain, node, is ≤ 3cm * Implementation of a method for taking into account movements and uncertainties (IGRT) for limiting the margin of CTV to PTV (PTV) so as not to exceed 7 cm large cumulative diameter of PTV * Performing a positron emission tomography with 18F-2-fluoro-2-deoxy-D-glucose (FDG-PET) 4 weeks before the inclusion * In case of cerebral metastases, MRI diagnostic is required * If locoregional disease is treated, controlled and non-progressive for more than three months (+/- 4 weeks) at baseline, synchronized initial tumor is possible * If metachronous metastases, locoregional disease previously treated should be monitored and considered not progressive for more than three months at baseline * In case of prior cancer other than HNSCC, complete remission for over 5 years is possible, any biopsy of metastases is left to the appreciation of referring physician * No chemotherapy or local treatment of metastases in the previous 6 months * Laboratory tests consistent with the achievement of chemotherapy: Leukocytes\> 3,000 / mm3 (including polynuclear\> 2000 / mm3) platelets\> 150,000 / mm3, serum glutamate oxaloacetate transminase (SGOT), serum glutamate pyruvate transaminase (SGPT), alkaline phosphatase, bilirubin \<2.5 upper limit of normal (ULN) * Affiliation to an health insurance * Informed Consent Form signed Exclusion Criteria: * Concomitant participation in other interventional clinical trial within 4 weeks before inclusion * Other prior ablative treatment of targets metastases (surgery, radio frequency) in the previous six months * metachronous primitive tumor (second cancer) uncontrolled. * contraindication to any systemic therapy (chemotherapy and / or targeted therapy) * Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, platin or cetuximab * Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV) * Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix * Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship * Pregnant or breast feeding women. Every woman who has childbearing potential, must have a negative pregnancy test (serum or urine) within 14 days previous treatment. Patients (men or women) must use a reliable method of contraception throughout treatment and for at least 6 months after discontinuation of chemotherapy.
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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
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Hôpital Nord Franche Comté
Montbéliard, 25209, France
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