NCT05291663

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

March 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 14, 2022

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

-Patients of (18 up to 75 years of age)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Mostafa El-sayed Abd Elwanis

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mostafa El-sayed Abd Elwanis

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 23, 2022

Study Start

March 20, 2022

Primary Completion

March 20, 2023

Study Completion

December 20, 2023

Last Updated

March 23, 2022

Record last verified: 2022-03