Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer

NCT05679856 | Unknown DMC FDA Device

• 1 other identifier: R02002-30908
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this prospective randomized clinical trial is to assess non inferiority in terms of local control achieved with single vocal cord hypofractionated radiotherapy compared to standard of care whole laryngeal radiotherapy in patients with T1aN0 glottic cancer . Secondary objectives include overall survival rate and to compare the Voice Handicap Index score between the 2 arms as well as acute and late toxicities. Patients are randomized in 1:1 ratio.

Conditions

Larynx Cancer Stage I; Glottic Carcinoma

Keywords

Larynx; Glottic; T1; hypofractionated radiotherapy; Vocal cord; Laryngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• Local control

  Rate of local control

  at 1 year follow up

Secondary Outcomes (4)

• Voice Handicap index

  Pretreatment- 2 months 6 months 1 year and 1 year follow upn

• Rates of acute toxicity

  Week 0 post-treatment and at 2-month follow-up

• Rates of chronic toxicity

  at 6 months - 1 year and 2 years follow up

• Overall survival

  at 2 year follow up

Study Arms (2)

Single vocal cord hypofractionated radiotherapy

EXPERIMENTAL

Hypofractionated radiotherapy 58.08Gy/16 fractions to affected vocal cord plus margins to account for motion and setup errors using IMRT/VMAT technique

Radiation: Hypofractionated single vocal cord irradiation

Whole laryngeal radiotherapy

ACTIVE COMPARATOR

Radiotherapy 63Gy/28 fractions to whole larynx from lower border of hyoid bone to lower border of cricoid cartilage using IMRT/VMAT technique

Radiation: Whole laryngeal radiotherapy

Interventions

Hypofractionated single vocal cord irradiation RADIATION

Only the affected vocal cord with additional margin to account for motion and setup errors will receive 58.08Gy/16 fractions using IMRT/VMAT technique

Single vocal cord hypofractionated radiotherapy

Whole laryngeal radiotherapy RADIATION

The whole larynx from lower border of hyoid bone to lower border of cricoid cartilage will receive 63Gy/28 fractions using IMRT/VMAT technique

Whole laryngeal radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T10N0 glottic squamous cell carcinoma
• Ability to provide written informed consent
• Eastern Cooperative Oncology Group performance status 0-2

You may not qualify if:

• Previous head and neck irradiation.
• WHO performance status above 2.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead
• Cairo University: collaborator

Study Sites (1)

National Cancer Institute, Cairo University

Cairo, 11796, Egypt

RECRUITING

Related Publications (5)

• Yamazaki H, Nishiyama K, Tanaka E, Koizumi M, Chatani M. Radiotherapy for early glottic carcinoma (T1N0M0): results of prospective randomized study of radiation fraction size and overall treatment time. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):77-82. doi: 10.1016/j.ijrobp.2005.06.014. Epub 2005 Sep 19.

  PMID: 16169681 BACKGROUND

• Gowda RV, Henk JM, Mais KL, Sykes AJ, Swindell R, Slevin NJ. Three weeks radiotherapy for T1 glottic cancer: the Christie and Royal Marsden Hospital Experience. Radiother Oncol. 2003 Aug;68(2):105-11. doi: 10.1016/s0167-8140(03)00059-8.

  PMID: 12972304 BACKGROUND

• Al-Mamgani A, Kwa SL, Tans L, Moring M, Fransen D, Mehilal R, Verduijn GM, Baatenburg de Jong RJ, Heijmen BJ, Levendag PC. Single Vocal Cord Irradiation: Image Guided Intensity Modulated Hypofractionated Radiation Therapy for T1a Glottic Cancer: Early Clinical Results. Int J Radiat Oncol Biol Phys. 2015 Oct 1;93(2):337-43. doi: 10.1016/j.ijrobp.2015.06.016. Epub 2015 Jun 14.

  PMID: 26264629 BACKGROUND

• Osman SO, Astreinidou E, de Boer HC, Keskin-Cambay F, Breedveld S, Voet P, Al-Mamgani A, Heijmen BJ, Levendag PC. IMRT for image-guided single vocal cord irradiation. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):989-97. doi: 10.1016/j.ijrobp.2010.12.022. Epub 2011 Feb 6.

  PMID: 21300449 BACKGROUND

• Dornfeld K, Simmons JR, Karnell L, Karnell M, Funk G, Yao M, Wacha J, Zimmerman B, Buatti JM. Radiation doses to structures within and adjacent to the larynx are correlated with long-term diet- and speech-related quality of life. Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):750-7. doi: 10.1016/j.ijrobp.2007.01.047. Epub 2007 Apr 6.

  PMID: 17418971 BACKGROUND

MeSH Terms

Conditions

Laryngeal Neoplasms; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Mohamed Mortada Elsharief

  NCI, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

• Tarek Shouman

  NCI, Cairo University, Egypt

  STUDY CHAIR

Central Study Contacts

Mohamed Mortada Elsharief

CONTACT

+0201128512966; drmohamedelcherif@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 11, 2023
• Study Start: January 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 11, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)