Effect of Accelerated RTH in Squamous Cell Carcinoma in Head and Neck

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Retrospective Study of Effect of Accelerated Radiation Therapy , Six Fractions Per Week , for Squamous Cell Carcinoma of Head and Neck.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05291663
• Other study ID #: RTH in head & neck tumors
• Status: Not yet recruiting
• Start date: March 20, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: Zienab Kamel
• Phone: +201022997677
• Email: zienab95kamel[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of the efficacy of the accelerated radiotherapy in squamous cell carcinoma of head and neck

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 20, 2023
• Est. primary completion date: March 20, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. — View Citation

Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Piñeros 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 2 — View 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. Review. — View 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 Ju — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine progression-free survival rate	Determine the toxicity and loco-regional control by using accelerated RTH in squamous cell carcinoma in head and neck	Baseline