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NCT Number: NCT03865277

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

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Faculty, Albert-Ludwigs-Universität Freiburg, Department of Radiation Oncology, Freiburg im Breisgau, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dose-escalated radiochemotherapy

Radiation

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

Radiation

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

Radiation

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.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Troost, Prof.Dr.Dr.

CONTACT

[email protected]

+49 351 458 7433

Mechthild Krause, Prof. Dr.

CONTACT

[email protected]

+49 351 458 2238

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging: Multi-center, Randomized Phase-II-trial

Acronym: INDIRA-MISO

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Mar 6, 2019
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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