Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy  (MART)

National Cancer Institute, Egypt

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Head and Neck Cancer

Treatments: Radiation: Standard dose; Radiation: Dose escalation

Study type: Interventional

Funder types: Other

Identifiers

NCT04933357

RO2010-30912

Details and patient eligibility

About

This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• More than or equal to 18 years old. ECOG Performance Scale (0-2). Histological confirmation of SCC of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx.

Clinical stage II-IVB (AJCC, 8th edition). Multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (CCRT).

Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion criteria

• Stage I/II glottic cancer. Patients who underwent surgery for the primary tumor location. Distant metastases. Inability to undergo PET-CT or MRI. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Dose escalation

Experimental group

Treatment:

Radiation: Dose escalation

Standard dose

Active Comparator group

Treatment:

Radiation: Standard dose