Head and Neck CancerPhase 2/3MARTNCT04933357
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy 
A Phase 2/3 study testing Dose escalation and Standard dose in people with Head and Neck Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Dose escalation and Standard dose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Sep 2019to Sep 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
May Ashour contact
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
Roa El-Tagy, roa.eltagy@gmail.com
About this study
Official title: Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Dose escalation, Standard dose
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalationRadiation
Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost
Standard doseRadiation
Standard dose to good responders to achieve dose equivalent of 70 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Not described Receives: Radiation: Dose escalation |
| Standard dose | Active comparator | Not described Receives: Radiation: Standard dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco-regional control of HNSCC patients.
Measured: 2 years loco-regional control.
Secondary outcomes (3)
Acute radiation toxicity
Measured: During treatment and up to 6 months post treatment.
Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.
Measured: 2-4 weeks after start of treatment
Overall survival
Measured: 2 years overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start16 Sep 2019
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roa AbdulRahim El-Tagy, National Cancer Institute, Egypt
- Investigators
- Tarek Shouman, Study director, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933357
- Sponsor's protocol ID
- RO2010-30912
- Acronym
- MART
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging
- ClinicalTrials.gov ID
- NCT04933357
- Acronym / sponsor ID
- MART / RO2010-30912
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Radiation: Dose escalation |
| Standard dose | Active comparator | Radiation: Standard dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose escalationDose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost | Radiation | Dose escalation |
| Standard doseStandard dose to good responders to achieve dose equivalent of 70 Gy. | Radiation | Standard dose |
Primary outcome
Loco-regional control of HNSCC patients.
Time frame: 2 years loco-regional control.
3 secondary outcomes
Acute radiation toxicity
Time frame: During treatment and up to 6 months post treatment.
Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.
Time frame: 2-4 weeks after start of treatment
Overall survival
Time frame: 2 years overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May Ashour contact
Tarek Shouman study director
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dose escalation and Standard dose in people with Head and Neck Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roa El-Tagy (002-01222410771, roa.eltagy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loco-regional control of HNSCC patients. (time frame: 2 years loco-regional control.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.