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

Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04933357

Acronym

MART

Enrollment

Registered

2021-06-21

Start date

2019-09-16

Completion date

2022-09-30

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Brief summary

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.

Interventions

RADIATIONDose escalation

Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost

RADIATIONStandard dose

Standard dose to good responders to achieve dose equivalent of 70 Gy.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Loco-regional control of HNSCC patients.	2 years loco-regional control.

Secondary

Measure	Time frame
Acute radiation toxicity	During treatment and up to 6 months post treatment.
Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.	2-4 weeks after start of treatment
Overall survival	2 years overall survival

Countries

Egypt

Contacts

Primary ContactRoa El-Tagy

roa.eltagy@gmail.com002-01222410771

Backup ContactMay Ashour

may25s@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy ￼