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COMPLETED

NCT02528955

PHASE2

De-Intensification Radiotherapy Postoperative Head Neck

Sponsor: University of Erlangen-Nürnberg Medical School

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2014-10

Completion Date

2025-09

Last Updated

2026-07-31

Healthy Volunteers

Conditions

Cancer of Head and Neck

Interventions

RADIATION

A: De-Intensification RT primary tumor region

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

RADIATION

B: De-Intensification RT contralateral lymph nodes

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

RADIATION

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

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

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

Locations (1)

Dept. of Radiooncology, University Hospital

Erlangen, Germany

Clinical Research Directory

De-Intensification Radiotherapy Postoperative Head Neck

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)