Back to resultsMultimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy  (MART)
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dose escalation
Standard dose
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
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.
Sites / Locations
- National Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dose escalation
Standard dose
Arm Description
Outcomes
Primary Outcome Measures
Loco-regional control of HNSCC patients.
Secondary Outcome Measures
Acute radiation toxicity
Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.
Overall survival
Full Information
NCT ID
NCT04933357
First Posted
June 15, 2021
Last Updated
June 15, 2021
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04933357
Brief Title
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy 
Acronym
MART
Official Title
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation
Arm Type
Experimental
Arm Title
Standard dose
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Dose escalation
Intervention Description
Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost
Intervention Type
Radiation
Intervention Name(s)
Standard dose
Intervention Description
Standard dose to good responders to achieve dose equivalent of 70 Gy.
Primary Outcome Measure Information:
Title
Loco-regional control of HNSCC patients.
Time Frame
2 years loco-regional control.
Secondary Outcome Measure Information:
Title
Acute radiation toxicity
Time Frame
During treatment and up to 6 months post treatment.
Title
Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.
Time Frame
2-4 weeks after start of treatment
Title
Overall survival
Time Frame
2 years overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roa El-Tagy
Phone
002-01222410771
Email
roa.eltagy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
May Ashour
Email
may25s@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Shouman
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roa El-Tagy
Email
roa.eltagy@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy 
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