Clinical trial NCT05291663: Effect of Accelerated RTH in Squamous Cell Carcinoma in Head and Neck
Official title: Retrospective Study of Effect of Accelerated Radiation Therapy , Six Fractions Per Week , for Squamous Cell Carcinoma of Head and Neck.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Patients of (18 up to 75 years of age)

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with previous irradiation to head and neck.
* Pregnant or lactating women.
* Patients with impaired heart or lung diseases.

Primary outcomes:
measure: Determine progression-free survival rate
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mostafa El-sayed Abd Elwanis
role: STUDY_DIRECTOR
References:
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citation: Windon 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.
citation: Blot 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.
citation: Johnson 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.