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Can a shorter radiation course tame side effects in head and neck cancer?

NCT ID NCT01211938

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

60 people

The number who actually took part.

Started

Jun 2010

Finished

Feb 2017

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 70 years

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: * 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

  • Institut Gustave Roussy

    Villejuif, 94800, France

More trials for these conditions

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