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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05291663
Collaborator
(none)
100
Enrollment
21
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study of Effect of Accelerated Radiation Therapy , Six Fractions Per Week , for Squamous Cell Carcinoma of Head and Neck.
    Anticipated Study Start Date :
    Mar 20, 2022
    Anticipated Primary Completion Date :
    Mar 20, 2023
    Anticipated Study Completion Date :
    Dec 20, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Determine progression-free survival rate [Baseline]

      Determine the toxicity and loco-regional control by using accelerated RTH in squamous cell carcinoma in head and neck

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Mostafa El-sayed Abd Elwanis, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zienab Kamel Mahmoud, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05291663
    Other Study ID Numbers:
    • RTH in head & neck tumors
    First Posted:
    Mar 23, 2022
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck

    Study Results

    No Results Posted as of Mar 23, 2022