Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging

NCT03865277 · tracked via the Priya Life Science Germany tracker

Sponsor

Technische Universität Dresden

Phase

Phase 2

Started

2024-07-01

Last updated

2023-09-11

Condition(s) studied

Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

dose-escalated radiochemotherapydose-escalated radiochemotherapy with carbon ion booststandard radiochemotherapy

dose-escalated radiochemotherapy: Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial. Present standard chemotherapy is cisplatinum 40 mg/m²/week (chemotherapy over the whole course of radiotherapy). Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region, 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes and, if "hypoxic" and randomized to the intervention arm, 77 Gy(RBE)/ 2.2 Gy(RBE) per fraction to the primary tumor and lymphonode metastases \> 2 cm. Radiotherapy is always applied with 5 fractions per week.

dose-escalated radiochemotherapy with carbon ion boost: Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial. Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region, 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes and, if "hypoxic" and treated in the study site Heidelberg, 77 Gy(RBE)/ 2.2 Gy(RBE) per fraction to the primary tumor and lymphonode metastases \> 2 cm using a carbon ion boost. Radiotherapy is always applied with 5 fractions per week.

standard radiochemotherapy: Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial. Present standard chemotherapy is cisplatinum 40 mg/m²/week (chemotherapy over the whole course of radiotherapy). Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region and 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes. Radiotherapy is always applied with 5 fractions per week.

Study summary

The trial evaluates the value of radiation dose escalation based on Hypoxia detection by 18F\_misonidazole Positron Emission Tomography (18F-MISO-PET) for primary radiochemotherapy of head and neck squamous cell carcinoma. Patients negative for human papillomavirus (HPV) and with hypoxic tumours after 2 weeks of radiochemotherapy are randomized to completion of standard radiochemotherapy or radiochemotherapy with escalated radiation dose. An additional interventional arm includes a carbon ion boost. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age: older than 18 years * WHO (ECOG) performance status 0-2 * Histological proven HNSCC * HPV negative tumors or HPV positive tumors * Stage III, IVA or IVB HNSCC according to UICC and AJCC guidelines * Tumor classified as irresectable or patient inoperable or patient refused surgery * Tumor extension and localization suitable for radiochemotherapy with curative intent * Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications) * Dental examination and -treatment before start of therapy * For women with childbearing potential and men in reproductive ages adequate contraception. * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * Refusal of the patients to take part in the trial * Presence of distant metastases (UICC stage IVC) * Previous radiotherapy in the head and neck region * Second malignancy that is likely to require treatment during the trial intervention or follow-up period or that, in the opinion of the physician, has a considerable risk of recurrence or metastases within the follow-up period * Serious disease or medical condition with life expectancy of less than one year * Participation in competing interventional trial on cancer treatment * Patients who are not suitable for radiochemotherapy * Pregnant or lactating women * Patients not able to understand the character and individual consequences of the trial * Nasopharyngeal Carcinomas

Primary outcome measure(s)

local tumour control — Local tumor control 2 years after end of treatment
Local tumour control (MRI, CT, PET or clinical evaluation) in the randomized dose-escalated arm compared to the randomized non dose escalated arm (arms 1 and 2).

Trial sites (8)

Facility	City	Region
Medical Faculty, Albert-Ludwigs-Universität Freiburg, Department of Radiation Oncology	Freiburg im Breisgau	Baden-Wurttemberg
Department of Radiation Oncology Heidelberg University Medical School	Heidelberg	Baden-Wurttemberg
Universitätsmedizin Mannheim, Klinik für Strahlentherapie und Radioonkologie	Mannheim	Baden-Wurttemberg
Uniklinikum Wuerzburg	Würzburg	Bavaria
Mechthild Krause	Dresden	Saxony
Universitätsklinikum Leipzig	Leipzig	Saxony
Charité University Hospital	Berlin	Germany
Ludwig-Maximilian-Universität, Klinikum Großhadern	München	Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03865277 on ClinicalTrials.gov ↗ ← All trials in Germany