Locally Advanced Head and Neck CancerNCT03699969
A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
A study testing Hypofractionated dose escalated VMAT in people with Locally Advanced Head and Neck Cancer, run by Cairo University.
Trial summary
To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Head and Neck Cancer
- What is being tested?
- Hypofractionated dose escalated VMAT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 15 Oct 2018
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤70 years old.
- Histopathologically confirmed squamous cell carcinoma of head and neck.
- Locally advanced tumors (T3-T4 \&/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition).
- Patients not exposed to radical surgery for current disease.
- Performance status (ECOG) 2 or less.
- No associated co-morbidity with contraindication to chemotherapy.
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- Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L)
- Accepted renal functions. (BUN \& serum creatinine <1.5x upper limit of normal value with normal GFR).
- Accepted liver functions. (total bilirubin and direct bilirubin < 1.5 x ULN \& alanine aminotransferase and aspartate aminotransferase < 3 x ULN)
- Informed consent.
Who cannot join
- Patients with distant metastatic lesions, as detected by imaging techniques.
- Patients with history of other head and neck malignancies.
- Patients with history of previous head and neck irradiation.
- Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection.
- Women who are pregnant or breast feeding.
About this study
Official title: A Clinical Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer
Read the detailed description
patients were randomized to receive either: 70Gy in 35fx in 7wks at 2Gy/fx concurrently with weekly cisplatin 40mg/m2 (Arm A) or 74Gy in 33 fractions (fx) in 6.5 weeks at 2.24Gy/fx (Arm B). Volumetric Modulated Arc Therapy (VMAT) plans were created for both treatment arms
- Conditions
- Locally Advanced Head and Neck Cancer
- Being tested
- Hypofractionated dose escalated VMAT
- Keywords
- Hypofractionation, VMAT, head and neck cancer
- 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.
Hypofractionated dose escalated VMATRadiation
measure the local control, progression free survival and overall survival
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated dose escalated VMAT | Experimental | Hypofractionated dose escalated VMAT radiotherapy Receives: Radiation: Hypofractionated dose escalated VMAT |
| Conventional concurrent chemoradiation | No intervention | Conventional concurrent chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control in the two arms
Local control by RECIST criteria
Measured: 33 months
Secondary outcomes (2)
The progression free survival in the two arms
The time (in months) from the end of radiotherapy to the date of first progression
Measured: 33 months
The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms
The number of patients who develop radiotherapy toxicity as assessed by CTCAE protocol Version 4.0
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2016
- Primary completion1 Oct 2018
- Study completion15 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699969
- Sponsor's protocol ID
- HN12016
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03699969
- Acronym / sponsor ID
- HN12016
- Conditions
- Locally Advanced Head and Neck Cancer
- Keywords
- Hypofractionation, VMAT, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (estimated)
- First posted
- 9 Oct 2018 (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.
To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer
Detailed description
patients were randomized to receive either: 70Gy in 35fx in 7wks at 2Gy/fx concurrently with weekly cisplatin 40mg/m2 (Arm A) or 74Gy in 33 fractions (fx) in 6.5 weeks at 2.24Gy/fx (Arm B). Volumetric Modulated Arc Therapy (VMAT) plans were created for both treatment arms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated dose escalated VMAT | Experimental | Radiation: Hypofractionated dose escalated VMATHypofractionated dose escalated VMAT radiotherapy |
| Conventional concurrent chemoradiation | No intervention | –Conventional concurrent chemoradiation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and ≤70 years old.
- Histopathologically confirmed squamous cell carcinoma of head and neck.
- Locally advanced tumors (T3-T4 \&/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition).
- Patients not exposed to radical surgery for current disease.
- Performance status (ECOG) 2 or less.
Key exclusion criteria (5 listed)
- Patients with distant metastatic lesions, as detected by imaging techniques.
- Patients with history of other head and neck malignancies.
- Patients with history of previous head and neck irradiation.
- Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection.
- Women who are pregnant or breast feeding.
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 |
|---|---|---|
| Hypofractionated dose escalated VMATmeasure the local control, progression free survival and overall survival | Radiation | Hypofractionated dose escalated VMAT |
Primary outcome
Local control in the two arms
Time frame: 33 months
Local control by RECIST criteria
2 secondary outcomes
The progression free survival in the two arms
Time frame: 33 months
The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms
Time frame: 33 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated dose escalated VMAT in people with Locally Advanced Head and Neck Cancer, run by Cairo University.
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 10 inclusion and 5 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control in the two arms (time frame: 33 months). 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 11 Oct 2018.