Can a shorter radiation course tame side effects in head and neck cancer?
NCT ID NCT01211938
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial is testing two different ways of delivering a second course of radiation to people whose head or neck cancer has come back after prior radiation. One approach uses a single daily dose of radiation combined with two chemotherapy drugs given every other week over 11 weeks. The other uses a more frequent, smaller-dose radiation schedule combined with a targeted therapy called cetuximab over 5 weeks. The goal is to see which approach causes fewer severe side effects and whether either helps control the cancer longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (single-fraction with 5FU and Hydrea, or hyperfractionated with cetuximab)
- What this could lead to
- If successful, this could identify a safer way to deliver a second course of radiation to people with recurrent head and neck cancer, potentially improving their quality of life and survival.
- What could go wrong
- This is an early-stage trial with a small number of patients, so results may not apply broadly. Reirradiation carries risks of severe side effects, and the added drugs (5FU, Hydrea, cetuximab) can cause their own toxicities.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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60 people
The number who actually took part.
- Started
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Jun 2010
- Finished
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Feb 2017
- 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 70 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: * Recurrent or second upper aerodigestive tract carcinoma in an area previously irradiated at a dose of \>= 50 Gy * Squamous cell carcinoma * No grade III or IV sequels linked to the first radiation therapy (excepted radiation sequels of salivary glands) * Relapse or second carcinoma (clinically invasive and/or lymph node recurrence \>= 3 cm and/or the association of a local and lymph node recurrence * Oral cavity, pharynx, larynx (if rT4), cervical region (if \>3cm) * No distant metastases confirmed by chest CT scan, abdominal ultrasound (or CT scan) in case of abnormal liver function, and bone scintigraphy in case of local symptoms * Surgery in the previously irradiated region allowing a macroscopically adequate resection * Surgery and vascular protection with a myocutaneous or free flap * Interval \> = 6 months between the end of the first radiation treatment and surgery in the previously irradiated area * Wound healing allowing reirradiation within an interval of 8 weeks after surgery in the previouly irradiated area. * No participation in a clinical trial during the 30 days preceding inclusion * Age between 18 et 70 years. * Performance Status 0 or 1 according to WHO criteria. * Hematological function : neutrophils \* 2 x 106/l, platelets : \* 100 x 106/l, hemoglobin : \* 10 g/dl (or 6.2 mmol/l) * Liver function : total bilirubin (normal) ; ASAT (SGOT) and ALAT (SGPT) \* 2.5 \* upper limit of normal (ULN) in each centre ; alkaline phosphatases \* 5 \* ULN. Patients whose ASAT or ALAT levels \> 1.5 \* ULN associated with alkaline phosphatases \* 2.5 \* ULN are not eligible for the trial * Renal function : serum creatinine \* 120 \*mol/l (1.4 mg/dl) ; if creatinine level is \> 120 \*mol/l, creatinine clearance should be \* 60 ml/min. * Written consent of participants Exclusion Criteria: * Superficial recurrence not associated with a lymph node relapse, isolated lymph node recurrence measuring less than 3 cm * Distant metastases * Grade 3 or 4 sequels of first radiation therapy (excepted salivary gland sequels) * Macroscopically inadequate surgery * Delay in wound healing obliging reirradiation to be postponed beyond 8 weeks. * \> Grade 3 Toxicity induced by chemotherapy administered during a previous treatment * Hypersensitivity to Erbitux * Concomitant severe comorbidities (non exhaustive list) * Unstable cardiac comorbidity in spite of treatment. * Neurological or psychiatric history such as dementia, convulsions. * Severe uncontrolled infection * Obstructive bronchopneumopathy which required hospitalisation during the year preceding inclusion. * Factors (psychological, familial, social or geographic) likely to hinder patient compliance with the study protocol and follow-up are considered exclusion criteria. These factors should be discussed with the patient before enrollment in the trial * Women who are pregnant, breast-feeding or of birthgiving age without effective contraception
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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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Institut Gustave Roussy
Villejuif, 94800, France
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