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Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer (VC-Larynx)

Primary Purpose

Larynx Cancer Stage I, Glottic Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hypofractionated single vocal cord irradiation
Whole laryngeal radiotherapy
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Larynx Cancer Stage I focused on measuring Larynx, Glottic, T1, hypofractionated radiotherapy, Vocal cord, Laryngeal carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: T10N0 glottic squamous cell carcinoma Ability to provide written informed consent Eastern Cooperative Oncology Group performance status 0-2 Exclusion Criteria: Previous head and neck irradiation. WHO performance status above 2.

Sites / Locations

  • National Cancer Institute, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single vocal cord hypofractionated radiotherapy

Whole laryngeal radiotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Local control
Rate of local control

Secondary Outcome Measures

Voice Handicap index
Voice Handicap index score Scores are rated on a 0-4 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.
Rates of acute toxicity
Rates of acute toxicity as per CTCAE v5.0
Rates of chronic toxicity
Rates of chronic toxicity as per CTCAE v5.0
Overall survival
Overall survival

Full Information

First Posted
December 12, 2022
Last Updated
January 10, 2023
Sponsor
National Cancer Institute, Egypt
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05679856
Brief Title
Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer
Acronym
VC-Larynx
Official Title
Vocal Cord Only Hypofractionated Radiotherapy vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Most laryngeal cancers present in early stage and more than two thirds of it occur in the glottic region(T1-T2). Early glottic carcinoma is historically treated with conventional radiotherapy using large box fields (from lower border of hyoid to lower border of cricoid), using wedged parallel opposed photon beams. In spite of good local control rate of more than 90% for T1a glottic cases, the tumor-free contralateral vocal cord, arytenoids, thyroid cartilage, and all muscles responsible for opening and closing the vocal cords, the swallowing muscles, carotid arteries and thyroid gland are exposed to high radiation doses (fully or partially) which could lead to an increased probability of complications that negatively influence the quality of life of these patients. Typical complications have involved voice/ speech impairment, diet problems (swallowing, trismus), arytenoids edema, an increased risk of strokes, and reduced treatment options for previously irradiated patients. Many studies showed that increasing fraction size and shortening the overall treatment time (hypofractionated radiotherapy) could result in better local control of T1 glottic cancer The use of 63Gy/28 Fractions(Fx) showed superior local control compared with conventional use of 66Gy/33Fx with shorter overall treatment time. Based on this study this dose is the standard in our institute. In contrast to the traditional radiotherapy principle to treat the whole larynx, surgical laser excision of T1a glottic cancer involves removal of gross tumor with minimal, often sub-millimeter, excisional margins with good oncological outcome and good quality of voice. Similar to this surgical concept and with modern radiotherapy IMRT/VMAT technique, the approach of single vocal cord irradiation (SVCI) was introduced. A study of 30 patients with T1a glottis cancer treated by image guided vocal cord radiotherapy was published in 2015 and it showed 100% local control at 2 years and with no grade 3 toxicities reported and better quality of voice when compared to historical cohorts Dosimetric analysis showed that IMRT resulted in markedly reducing the dose to contralateral cord, arytenoids, thyroid cartilage, inferior constrictor muscle and carotid arteries. To date no prospective phase 3 trial was done to compare treatment outcome and toxicity profile of vocal cord only hypofractionated radiotherapy vs traditional whole laryngeal radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Larynx Cancer Stage I, Glottic Carcinoma
Keywords
Larynx, Glottic, T1, hypofractionated radiotherapy, Vocal cord, Laryngeal carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single vocal cord hypofractionated radiotherapy
Arm Type
Experimental
Arm Description
Hypofractionated radiotherapy 58.08Gy/16 fractions to affected vocal cord plus margins to account for motion and setup errors using IMRT/VMAT technique
Arm Title
Whole laryngeal radiotherapy
Arm Type
Active Comparator
Arm Description
Radiotherapy 63Gy/28 fractions to whole larynx from lower border of hyoid bone to lower border of cricoid cartilage using IMRT/VMAT technique
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated single vocal cord irradiation
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Whole laryngeal radiotherapy
Intervention Description
The whole larynx from lower border of hyoid bone to lower border of cricoid cartilage will receive 63Gy/28 fractions using IMRT/VMAT technique
Primary Outcome Measure Information:
Title
Local control
Description
Rate of local control
Time Frame
at 1 year follow up
Secondary Outcome Measure Information:
Title
Voice Handicap index
Description
Voice Handicap index score Scores are rated on a 0-4 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.
Time Frame
Pretreatment- 2 months 6 months 1 year and 1 year follow upn
Title
Rates of acute toxicity
Description
Rates of acute toxicity as per CTCAE v5.0
Time Frame
Week 0 post-treatment and at 2-month follow-up
Title
Rates of chronic toxicity
Description
Rates of chronic toxicity as per CTCAE v5.0
Time Frame
at 6 months - 1 year and 2 years follow up
Title
Overall survival
Description
Overall survival
Time Frame
at 2 year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: T10N0 glottic squamous cell carcinoma Ability to provide written informed consent Eastern Cooperative Oncology Group performance status 0-2 Exclusion Criteria: Previous head and neck irradiation. WHO performance status above 2.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Mortada Elsharief
Phone
+0201128512966
Email
drmohamedelcherif@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Mortada Elsharief
Organizational Affiliation
NCI, Cairo University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek Shouman
Organizational Affiliation
NCI, Cairo University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Institute, Cairo University
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Mortada Elsharief
Phone
+0201128512966
Email
drmohamedelcherif@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16169681
Citation
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.
Results Reference
background
PubMed Identifier
12972304
Citation
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.
Results Reference
background
PubMed Identifier
26264629
Citation
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.
Results Reference
background
PubMed Identifier
21300449
Citation
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.
Results Reference
background
PubMed Identifier
17418971
Citation
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.
Results Reference
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Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer

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