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Can less radiation be safer without sacrificing cancer control?

NCT ID NCT02528955

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tested whether giving lower doses of radiation after surgery for head and neck cancer could reduce long-term side effects like dry mouth and trouble swallowing, while still keeping the cancer from coming back. About 200 patients with certain stages of oral, throat, or voice box cancer received one of three reduced-radiation plans. The goal was to see if the cancer recurrence rate after two years stayed low enough to make these gentler treatments a new standard.

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
What this could lead to
If successful, this could show that some patients can get lower radiation doses after surgery, reducing long-term side effects like dry mouth and swallowing problems without increasing cancer recurrence.
What could go wrong
This is a Phase 2 study with 200 patients, so results are not definitive. Lower radiation might lead to higher recurrence rates in some patients, and the findings may not apply to all head and neck cancers.

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

200 people

The number who actually took part.

Start date

Oct 2014

Finished

Sep 2025

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.

Inclusion Criteria: 1. Histologic proven squamous cell carcinoma of the oral cavity/larynx/oro- or hypopharynx 2. Postoperative tumor status: * Oral cavity, oropharynx or larynx: pT1-3, pN0-pN2b * Hypopharynx: pT1-2; pN1 3. Patients that fulfill one or both of the following criteria: * ≤ pT2, R ≥ 5 mm, L0, Pn0 * ≤ 3 ipsilateral lymph node metastases (if a contralateral adequate neck dissection is performed, no contralateral neck dissection is recommended in patients with strictly ipsilateral localised tumors of the oropharynx or oral cavity) 4. R0-Resection (resection margin ≥ 1mm) 5. No distant metastasis cM0 6. age ≥ 18 years, no upper age limit 7. ECOG ≤ 2 8. Patients that understood protocol contents and are able to behave according to protocol 9. Signed study-specific consent form prior to therapy 10. In case of indicated simultaneous chemotherapy: * adequate bone marrow function (leucocytes \> 3,5x10\^3, platelets \> 100x 10\^3, hemoglobin \> 10g/dl * sufficient liver function: bilirubin \< 2,0mg/dl, ALT, AST \< less than 3 times upper limit of normal * sufficient renal function: normal serum creatinine, glomerular filtration rate \> 60ml/min Exclusion Criteria: 1. pregnant or lactating/nursing women 2. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment 3. Any condition potentially hampering compliance with the study protocol and follow-up schedule 4. On-treatment participation on other trials 5. R1 or R2 resection status 6. pN2c and pN3 7. cM1 8. prior radiotherapy in the head and neck region , prior chemo- or immunotherapy (neoadjuvant/induction) 9. time between surgery and beginning of radio(chemo)therapy \> 6 weeks 10. Prior (\> 4 months before beginning of radio(chemo)therapy) neck dissection 11. In case of indicated simultaneous chemotherapy: * reduced hearing ability (especially upper frequency range) * known dihydropyrimidindehydrogenase (DPD) deficiency * simultaneous therapy with brivudin or other DPD-inhibitors * uncontrolled serious disease, including physical and mental diseases, for example within last 6 months:instable angina pectoris, heart attack, serious cardiac dysrhythmias, stroke, serious carotid stenosis, neurologic or psychiatric disorders including epilepsy, dementia, psychosis; uncontrolled infection; liver cirrhosis Child B or C, severe hepatic impairment; severe blood count changes; severe renal impairment, HIV

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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

  • Dept. of Radiooncology, University Hospital

    Erlangen, 91054, Germany

More trials for these conditions

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