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JOURNAL ONKOLOGIE – STUDIE
INDIRA-MISO

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

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NCT-Nummer:
NCT03865277

Studienbeginn:
Juli 2024

Letztes Update:
11.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Hypoxia, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Technische Universität Dresden

Collaborator:
-

Studienleiter

Mechthild Krause, Prof.
Study Chair
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Kontakt

Mechthild Krause, Prof. Dr.
Kontakt:
Phone: +49 351 458 2238
E-Mail: mechthild.krause@uniklinikum-dresden.de» Kontaktdaten anzeigen
Esther Troost, Prof.Dr.Dr.
Kontakt:
Phone: +49 351 458 7433
E-Mail: esther.troost@uniklinikum-dresden.de» Kontaktdaten anzeigen

Studienlocations
(3 von 8)

Alle anzeigen

Studien-Informationen

Detailed Description:

Previous preclinical data and a prospective validated patient cohort have shown that patients

with head and neck squamous cell carcinoma, whose tumours are hypoxic after 2 weeks of

primary radiochmeotherapy, have a significantly lower chance of locoregional tumour control.

The multi-center 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 (70 Gy) or radiochemotherapy with

escalated radiation dose (77 Gy). An additional interventional arm includes a carbon ion

boost to 77 Gy. HPV positive tumours can be included in a control arm. Primary endpoint is

local tumour control 2 years after radiochemotherapy. Secondary endpoints include acute and

late toxicity (CTCAE 5.0), regional tumor control, overall survival, disease free survival,

distant metastases, kinetics analysis of dynamic FMISO-PET scans, Quality of life (QoL). The

hypothesis is that local tumour control 2 years after radiochemotherapy is higher in the dose

escalated compared to the control arm.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. local tumour control (Time Frame - 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).



Secondary outcome:

1. late toxicity (Time Frame - 30 days to 2 years after radiochemotherapy):
late toxicity based on CTCAE 5.0

2. survival (Time Frame - 2 years after radiochemotherapy):
Overall survival

3. quality of life EORTC QLQ-C30/HN-35 (Time Frame - regularly up to 2 years after radiochemotherapy):
EORTC-QLQ (C30 and HN-35) Sheets (General for tumour diseases and specific for head and neck cancer)

4. acute toxicity (Time Frame - during treatment and up to 30 days after radiochemotherapy):
acute toxicity based on CTCAE 5.0

Studien-Arme

  • Other: standard radiochemotherapy, hypoxic
    HPV (-), hypoxic in 18F-MISO PET after 2 weeks of radiochemotherapy, randomized to standard radiation dose, 70 Gy standard radiochemotherapy
  • Experimental: dose-escalated radiochemotherapy, hypoxic
    HPV (-), hypoxic in 18F-MISO PET after 2 weeks of radiochemotherapy, randomized to escalated radiation dose, 77 Gy radiochemotherapy
  • Experimental: escalated radiochemoth., carbon boost, hypoxic
    HPV (-), hypoxic in 18F-MISO PET after 2 weeks of radiochemotherapy, non-randomised arm (only possible in the trial center Heidelberg), 77 Gy radiochemotherapy (boost with carbon)
  • Other: standard radiochemotherapy, oxic
    HPV (-), oxic in 18F-MISO PET after 2 weeks of radiochemotherapy, 70 Gy standard radiochemotherapy
  • Other: standard radiochemotherapy (70 Gy)
    HPV (+), HPV positive patients will get the same imaging and clinical examinations as HPV negative patients. This measure is necessary to further elucidate the prognostic role of hypoxia and HPV status and their correlation, the information will be important for consecutive clinical trials. 70 Gy standard radiochemotherapy.

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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