Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy 
MART
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 head-and-neck-cancer
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2019
CompletedFirst Submitted
Initial submission to the registry
June 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJune 21, 2021
June 1, 2021
3 years
June 15, 2021
June 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Loco-regional control of HNSCC patients.
2 years loco-regional control.
Secondary Outcomes (3)
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
Study Arms (2)
Dose escalation
EXPERIMENTALStandard dose
ACTIVE COMPARATORInterventions
Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost
Standard dose to good responders to achieve dose equivalent of 70 Gy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Institute
Cairo, 11796, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tarek Shouman
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
June 15, 2021
First Posted
June 21, 2021
Study Start
September 16, 2019
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
June 21, 2021
Record last verified: 2021-06