Head and Neck Squamous Cell CarcinomaNCT05291663
Effect of Accelerated RTH in Squamous Cell Carcinoma in Head and Neck
An observational study of Head and Neck Squamous Cell Carcinoma, run by Assiut University.
Trial summary
Evaluation of the efficacy of the accelerated radiotherapy in squamous cell carcinoma of head and neck Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2022to 20 Dec 2023
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: -Patients of (18 up to 75 years of age)
Who may be able to join
- Patients of (18 up to 75 years of age)
- Performance status of 0-2 according to ECOG scale.
- Patients with no prior chemotherapy, radiotherapy or surgery except for biopsy.
Who cannot join
- Patients with previous irradiation to head and neck.
- Pregnant or lactating women.
- Patients with impaired heart or lung diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retrospective Study of Effect of Accelerated Radiation Therapy , Six Fractions Per Week , for Squamous Cell Carcinoma of Head and Neck.
Evaluation of the efficacy of the accelerated radiotherapy in squamous cell carcinoma of head and neck
Read the detailed description
- HNSCC is the sixth most common cancer worldwide, with 890.000 new cases and 450.000 deaths in 2018.
- The incidence of HNSCC continues to rise and is anticipated to increase by 30% (that is, 1.08 million new cases annually) by 2030.
- Squamous cell carcinoma constitutes 90% of all head and neck cancers and it predominates in males.
- Risk factors such as cigarette consumption and alcohol consumption, are well established.
- Treatment decisions are guided by clinic-pathologic factors such as age and stage.
- Treatment of the majority of patients with HNSCC requires multimodality approaches.
- Radiotherapy or surgery alone can be considered as the standard treatment modality for patients having early head and neck squamous cell carcinoma.
- When conventionally fractionated radiotherapy is used, long-term tumor control can be achieved in less than 30% of patients with advanced head and neck carcinomas.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine progression-free survival rate
Determine the toxicity and loco-regional control by using accelerated RTH in squamous cell carcinoma in head and neck
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start20 Mar 2022 (estimated)
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zienab Kamel Mahmoud, Assiut University
- Investigators
- Mostafa El-sayed Abd Elwanis, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291663
- Sponsor's protocol ID
- RTH in head & neck tumors
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Pineros M, Znaor A, Bray F. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2019 Apr 15;144(8):1941-1953. doi: 10.1002/ijc.31937. Epub 2018 Dec 6.
PubMed 30350310Windon MJ, D'Souza G, Rettig EM, Westra WH, van Zante A, Wang SJ, Ryan WR, Mydlarz WK, Ha PK, Miles BA, Koch W, Gourin C, Eisele DW, Fakhry C. Increasing prevalence of human papillomavirus-positive oropharyngeal cancers among older adults. Cancer. 2018 Jul 15;124(14):2993-2999. doi: 10.1002/cncr.31385. Epub 2018 Apr 30.
PubMed 29710393Blot WJ, McLaughlin JK, Winn DM, Austin DF, Greenberg RS, Preston-Martin S, Bernstein L, Schoenberg JB, Stemhagen A, Fraumeni JF Jr. Smoking and drinking in relation to oral and pharyngeal cancer. Cancer Res. 1988 Jun 1;48(11):3282-7.
PubMed 3365707Johnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. Head and neck squamous cell carcinoma. Nat Rev Dis Primers. 2020 Nov 26;6(1):92. doi: 10.1038/s41572-020-00224-3.
PubMed 33243986
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Effect of Accelerated Radiation Therapy , Six Fractions Per Week , for Squamous Cell Carcinoma of Head and Neck.
- ClinicalTrials.gov ID
- NCT05291663
- Acronym / sponsor ID
- RTH in head & neck tumors
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (estimated)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 23 Mar 2022 (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.
Evaluation of the efficacy of the accelerated radiotherapy in squamous cell carcinoma of head and neck
Detailed description
- HNSCC is the sixth most common cancer worldwide, with 890.000 new cases and 450.000 deaths in 2018.
- The incidence of HNSCC continues to rise and is anticipated to increase by 30% (that is, 1.08 million new cases annually) by 2030.
- Squamous cell carcinoma constitutes 90% of all head and neck cancers and it predominates in males.
- Risk factors such as cigarette consumption and alcohol consumption, are well established.
- Treatment decisions are guided by clinic-pathologic factors such as age and stage.
- Treatment of the majority of patients with HNSCC requires multimodality approaches.
- Radiotherapy or surgery alone can be considered as the standard treatment modality for patients having early head and neck squamous cell carcinoma.
- When conventionally fractionated radiotherapy is used, long-term tumor control can be achieved in less than 30% of patients with advanced head and neck carcinomas.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- -Patients of (18 up to 75 years of age)
Key inclusion criteria (3 listed)
- Patients of (18 up to 75 years of age)
- Performance status of 0-2 according to ECOG scale.
- Patients with no prior chemotherapy, radiotherapy or surgery except for biopsy.
Key exclusion criteria (3 listed)
- Patients with previous irradiation to head and neck.
- Pregnant or lactating women.
- Patients with impaired heart or lung diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine progression-free survival rate
Time frame: Baseline
Determine the toxicity and loco-regional control by using accelerated RTH in squamous cell carcinoma in head and neck
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Results publication: PubMed 30350310Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Pineros M, Znaor A, Bray F. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2019 Apr 15;144(8):1941-1953. doi: 10.1002/ijc.31937. Epub 2018 Dec 6.
- Results publication: PubMed 29710393Windon MJ, D'Souza G, Rettig EM, Westra WH, van Zante A, Wang SJ, Ryan WR, Mydlarz WK, Ha PK, Miles BA, Koch W, Gourin C, Eisele DW, Fakhry C. Increasing prevalence of human papillomavirus-positive oropharyngeal cancers among older adults. Cancer. 2018 Jul 15;124(14):2993-2999. doi: 10.1002/cncr.31385. Epub 2018 Apr 30.
- Results publication: PubMed 3365707Blot WJ, McLaughlin JK, Winn DM, Austin DF, Greenberg RS, Preston-Martin S, Bernstein L, Schoenberg JB, Stemhagen A, Fraumeni JF Jr. Smoking and drinking in relation to oral and pharyngeal cancer. Cancer Res. 1988 Jun 1;48(11):3282-7.
- Results publication: PubMed 33243986Johnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. Head and neck squamous cell carcinoma. Nat Rev Dis Primers. 2020 Nov 26;6(1):92. doi: 10.1038/s41572-020-00224-3.
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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.
Mostafa El-sayed Abd Elwanis study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Assiut 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 3 inclusion and 3 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 23 Mar 2022. 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?
Contact Zienab Kamel (+201022997677, zienab95kamel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine progression-free survival rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291663, which also lists 4 linked publications.
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 23 Mar 2022.