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

Head and Neck Cancer Clinical Trial

— MART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933357
• Other study ID #: RO2010-30912
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 16, 2019
• Est. completion date: September 2022

Study information

• Verified date: June 2021
• Source: National Cancer Institute, Egypt
• Contact: Roa El-Tagy
• Phone: 002-01222410771
• Email: roa.eltagy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• Dose escalation
Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost
• Standard dose
Standard dose to good responders to achieve dose equivalent of 70 Gy.

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loco-regional control of HNSCC patients.		2 years loco-regional control.
Secondary	Acute radiation toxicity		During treatment and up to 6 months post treatment.
Secondary	Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.		2-4 weeks after start of treatment
Secondary	Overall survival		2 years overall survival