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Cancer of Head and NeckPhase 2DIREKHTNCT02528955

De-Intensification Radiotherapy Postoperative Head Neck

A Phase 2 study testing A: De-Intensification RT primary tumor region, B: De-Intensification RT contralateral lymph nodes and C. De-Intensification RT primary tumor region AND contralateral lymph nodes in people with Cancer of Head and Neck, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with >= pT3 and or pN+ postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of Head and Neck
What is being tested?
A: De-Intensification RT primary tumor region, B: De-Intensification RT contralateral lymph nodes and C. De-Intensification RT primary tumor region AND contralateral lymph nodes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteGermany
Study dates
Oct 2014to Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic proven squamous cell carcinoma of the oral cavity/larynx/oro- or hypopharynx
  • Postoperative tumor status:
  • Oral cavity, oropharynx or larynx: pT1-3, pN0-pN2b
  • Hypopharynx: pT1-2; pN1
  • Patients that fulfill one or both of the following criteria:
  • ≤ pT2, R ≥ 5 mm, L0, Pn0
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  • ≤ 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)
  • R0-Resection (resection margin ≥ 1mm)
  • No distant metastasis cM0
  • age ≥ 18 years, no upper age limit
  • ECOG ≤ 2
  • Patients that understood protocol contents and are able to behave according to protocol
  • Signed study-specific consent form prior to therapy
  • 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

Who cannot join

  • pregnant or lactating/nursing women
  • fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
  • Any condition potentially hampering compliance with the study protocol and follow-up schedule
  • On-treatment participation on other trials
  • R1 or R2 resection status
  • pN2c and pN3
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  • cM1
  • prior radiotherapy in the head and neck region , prior chemo- or immunotherapy (neoadjuvant/induction)
  • time between surgery and beginning of radio(chemo)therapy > 6 weeks
  • Prior (> 4 months before beginning of radio(chemo)therapy) neck dissection
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Dept. of Radiooncology, University Hospital

    Erlangen, 91054

Other trials in Germany

About this study

Official title: De-intensification of Postoperative Radiotherapy in Selected Patients With Head and Neck Cancer

In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with >= pT3 and or pN+ postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and or R1/2 resection.

Locoregional control rates are over 80% after surgery and radio(chemo)therapy. But many patients suffer from therapy-related long-term side-effects, like xerostomia, dysphagia, fibrosis, trismus etc.

The aim of this study is to investigate if depending on primary tumor stage, quality of resection ( resection margin) and number of lymph node metastasis and performed neck dissection an adapted de-intensified dose- and target volume concept may be performed without reducing locoregional-control but with reducing radiotherapy-related side-effects.

Read the detailed description

The study is a non-randomized phase-II trial. In total there are 3 therapy arms.

Patients are assigned to one of these therapy arms according to the tumor status and the quality and kind of surgery. The aim of this study is to investigate if a risk-adapted dose- and target-volume concept in clearly defined patient groups is possible to individualize postoperative radiotherapy without reducing locoregional-control but with reducing radiotherapy-related side-effects.

There are two main issues to investigate:

  1. Dose prescription in primary tumor region: In this study it should be investigated if a dose reduction to 56 Gy in the primary tumor region is possible, if the resection margin is >= 5mm, tumor stage is <=pT2 and if there are no other risk factors like perineural spread or peritumoral lymphangiosis.
  2. Target volume definition in elective lymph node levels It should be investigated if ipsilateral cervical lymph irradiation alone allows adequate locoregional control in selected patients: ipsilateral lymph node metastasis <=3 and contralateral pN0 (adequate contralateral selective neck dissection performed) or contralateral cN0 (in patients with strictly ipsilateral localized tumors of the oral cavity or oropharynx) Considering these facts 3 therapy groups are possible: A: Criteria:
  • pT2, R ≥ 5 mm, L0, Pn0
  • 3 lymph node metastasis or patients with < 3 ipsilateral lymph node metastasis and a bilateral primary tumor without adequate contralateral neck dissection Intervention:
  • Reduction of radiation dose in the primary tumor region to 56 Gy,
  • Elective Radiotherapy of both neck sides B: Criteria: •> pT2 and/or R < 5mm and/or L1 and/or Pn1 •≤ 3 ipsilateral lymph node metastasis (and contralateral pN0 (>= 6 resected lymph nodes) or contralateral cN0 in patients wih strictly ipsilateral localised ( >= 5 mm distance from midline) cancer of the oral cavity or oropharynx Intervention •No dose reduction in primary tumor region (prescribed dose in primary tumor region: 64 Gy) •Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation C: Criteria
  • pT2, R ≥ 5 mm, L0, Pn0
  • 3 ipsilateral lymph node metastasis (and contralateral pN0 (>= 6 resected lymph nodes) or contralateral cN0 in patients wih strictly ipsilateral localised ( >= 5 mm distance from midline) cancer of the oral cavity or oropharynx Intervention •Reduction of radiation dose in the primary tumor region to 56 Gy, AND •Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation In all arms the dose prescription for the lymph node regions is as follows: •elective lymph node level (either ipsi- or bilateral): 50 Gy •lymph node level with lymph node metastasis without extracapsular extension: 56Gy
  • lymph node level with lymph node metastasis with extracapsular extension: 64 Gy In all arms simultaneously chemotherapy is recommended in the following cases:
  • lymph node metastasis with extracapsular extension •>= 3 lymph node metastasis All patients are stratified according to HPV status. Additional investigations:
  • swallowing endoscopy (before, 6 and 24 months after radiotherapy)
  • translational research (especially individual radiosensitivity, immunologic parameters in peripheral blood during treatment)
  • QoL
Being tested
A: De-Intensification RT primary tumor region, B: De-Intensification RT contralateral lymph nodes, C. De-Intensification RT primary tumor region AND contralateral lymph nodes
Keywords
Head and neck cancer, postoperative, radiotherapy, de-intensification
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A: De-Intensification RT primary tumor regionRadiation

    A:

    • Reduction of radiation dose in the primary tumor region to 56 Gy,
    • Elective Radiotherapy of both neck sides

  • B: De-Intensification RT contralateral lymph nodesRadiation

    B:

    • No dose reduction in primary tumor region (prescribed dose in primary tumor region: 64 Gy)
    • Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation

  • C. De-Intensification RT primary tumor region AND contralateral lymph nodesRadiation

    C:

    • Reduction of radiation dose in the primary tumor region to 56 Gy, AND
    • Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation
Study groups in NCT02528955
Study groupRoleWhat they receive
A:De-Intensification Radiotherapy (RT) primary tumor regionActive comparatorA:De-Intensification Radiotherapy (RT) primary tumor region * ≤ pT2, R ≥ 5 mm, L0, Pn0 * > 3 lymph node metastasis or patients with < 3 ipsilateral lymph node metastasis and a bilateral primary tumor without adequate contralateral neck dissection
Receives: Radiation: A: De-Intensification RT primary tumor region
B:De-Intensification Radiotherapy contralateral lymph nodesActive comparator* > pT2 and/or R < 5mm and/or L1 and/or Pn1 * ≤ 3 ipsilateral lymph node metastasis (and contralateral pN0 (>= 6 resected lymph nodes) or contralateral cN0 in patients wih strictly ipsilateral localised ( >= 5 mm distance from midline) cancer of the oral cavity or oropharynx
Receives: Radiation: B: De-Intensification RT contralateral lymph nodes
C:De-Intensification RT primary tumor region /contralateral LNActive comparator* ≤ pT2, R ≥ 5 mm, L0, Pn0 * ≤ 3 ipsilateral lymph node metastasis (and contralateral pN0 (>= 6 resected lymph nodes) or contralateral cN0 in patients wih strictly ipsilateral localised ( >= 5 mm distance from midline) cancer of the oral cavity or oropharynx
Receives: Radiation: C. De-Intensification RT primary tumor region AND contralateral lymph nodes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. locoregional recurrence rate after 2 years

    (recurrence in-radiation field, radiation field margin, outside radiation field for example contralateral)

    Measured: 2 years

Secondary outcomes (6)

  1. Overall Survival

    Measured: after 2 and 5 years

  2. disease-free survival

    Measured: after 2 and 5 years

  3. distant-metastasis-free survival

    Measured: after 2 and 5 years

  4. acute toxicity according to ctc-ae v.4.0

    Measured: during therapy and up to 8 weeks after therapy

  5. late toxicity according to ctc-ae v.4.0

    Measured: follow-up period (5years)

  6. Quality of Life as measured by questionaires

    questionaires: EORTC QLQ-C30 and QLQ-H\&N35 and EAT-10

    Measured: before and during treatment and in the follow-up for 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2022
  4. Study completionSep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02528955
Sponsor's protocol ID
DIREKHT
Acronym
DIREKHT
Status last verified
Sep 2025
First submitted
10 Aug 2015
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No

Publications

  • Donaubauer AJ, Tomic O, Mogge L, Muller SK, Futsaether CM, Liland KH, Huynh BN, von der Grun J, Balermpas P, Fleischmann M, Hautmann MG, Steger F, Bohr C, Hehr T, Stromberger C, Budach V, Schymalla M, Engenhart-Cabillic R, Kocik L, Geinitz H, Nestle U, Klautke G, Scherl C, Schubert P, Corradini S, Fietkau R, Gaipl US, Frey B, Haderlein M. Exploratory immunomonitoring during radiochemotherapy in HNSCC and machine-learning reveal immune parameters associated with disease-free survival. NPJ Precis Oncol. 2026 Aug 31;10(1):337. doi: 10.1038/s41698-026-01658-w.

    PubMed 42675144

  • Haderlein M, Speer S, Ott O, Lettmaier S, Hecht M, Semrau S, Frey B, Scherl C, Iro H, Kesting M, Fietkau R. Dose Reduction to the Swallowing Apparatus and the Salivary Glands by De-Intensification of Postoperative Radiotherapy in Patients with Head and Neck Cancer: First (Treatment Planning) Results of the Prospective Multicenter DIREKHT Trial. Cancers (Basel). 2020 Feb 26;12(3):538. doi: 10.3390/cancers12030538.

    PubMed 32110958

  • Onbasi Y, Lettmaier S, Hecht M, Semrau S, Iro H, Kesting M, Fietkau R, Haderlein M. Is there a patient population with squamous cell carcinoma of the head and neck region who might benefit from de-intensification of postoperative radiotherapy? : A monocentric retrospective analysis of a previously defined low-risk patient population treated with standard-of-care radiotherapy. Strahlenther Onkol. 2019 Jun;195(6):482-495. doi: 10.1007/s00066-018-1415-y. Epub 2019 Jan 4.

    PubMed 30610355

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A: De-Intensification RT primary tumor region, B: De-Intensification RT contralateral lymph nodes and C. De-Intensification RT primary tumor region AND contralateral lymph nodes in people with Cancer of Head and Neck, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

locoregional recurrence rate after 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02528955, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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