DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC

Danish Head and Neck Cancer Group

Status and phase: Unknown; Phase 2

Conditions: Hypoxic Radioresistance; Locally Advanced Head and Neck Cancer; Radiotherapy

Treatments: Radiation: HART-CN

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02976051

DAHANCA 33

Details and patient eligibility

About

Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning

Full description

Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET.

Inclusion:

Patients must fulfill the following:

Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage III-IV larynx, pharynx, oral cavity
• Hypoxic FAZA-PET positive
• Indication for primary radio-chemotherapy
• Informed consent

Exclusion criteria

• HPV positive oropharynx cancer
• Primary surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Treatment with HART-CN

Experimental group

Description:

HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole

Treatment:

Radiation: HART-CN