Larynx Cancer Stage IVC-LarynxNCT05679856
Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer
A study testing Hypofractionated single vocal cord irradiation and Whole laryngeal radiotherapy in people with Larynx Cancer Stage I and Glottic Carcinoma, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Larynx Cancer Stage I, Glottic Carcinoma
- What is being tested?
- Hypofractionated single vocal cord irradiation and Whole laryngeal radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T10N0 glottic squamous cell carcinoma
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group performance status 0-2
Who cannot join
- Previous head and neck irradiation.
- WHO performance status above 2.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute, Cairo University
Cairo, 11796
Mohamed Mortada Elsharief, +0201128512966, drmohamedelcherif@gmail.com
About this study
Official title: Vocal Cord Only Hypofractionated Radiotherapy vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer
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.
Read the 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.
- Conditions
- Larynx Cancer Stage I, Glottic Carcinoma
- Being tested
- Hypofractionated single vocal cord irradiation, Whole laryngeal radiotherapy
- Keywords
- Larynx, Glottic, T1, hypofractionated radiotherapy, Vocal cord, Laryngeal carcinoma
- Medical subject headings
- Laryngeal Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated single vocal cord irradiationRadiation
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
Whole laryngeal radiotherapyRadiation
The whole larynx from lower border of hyoid bone to lower border of cricoid cartilage will receive 63Gy/28 fractions using IMRT/VMAT technique
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: Whole laryngeal radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
Rate of local control
Measured: at 1 year follow up
Secondary outcomes (4)
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.
Measured: Pretreatment- 2 months 6 months 1 year and 1 year follow upn
Rates of acute toxicity
Rates of acute toxicity as per CTCAE v5.0
Measured: Week 0 post-treatment and at 2-month follow-up
Rates of chronic toxicity
Rates of chronic toxicity as per CTCAE v5.0
Measured: at 6 months - 1 year and 2 years follow up
Overall survival
Overall survival
Measured: at 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Larynx Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Mohamed Mortada Elsharief, Principal investigator, NCI, Cairo University, EgyptTarek Shouman, Study chair, NCI, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679856
- Sponsor's protocol ID
- R02002-30908
- Acronym
- VC-Larynx
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16169681Gowda 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.
PubMed 12972304Al-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.
PubMed 26264629Osman 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.
PubMed 21300449Dornfeld 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.
PubMed 17418971Elsharief MM, Hassouna AH, Shouman T, Mosallam A, El-Badrawy A, Shawky A, Amin A, Abdelfatah SM. Single vocal cord irradiation (SVCI) vs whole laryngeal radiotherapy in the treatment of T1aN0 glottic cancer A prospective randomized trial. Radiother Oncol. 2026 Mar;216:111376. doi: 10.1016/j.radonc.2026.111376. Epub 2026 Jan 9.
PubMed 41520731
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vocal Cord Only Hypofractionated Radiotherapy vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer
- ClinicalTrials.gov ID
- NCT05679856
- Acronym / sponsor ID
- VC-Larynx / R02002-30908
- Conditions
- Larynx Cancer Stage I, Glottic Carcinoma
- Keywords
- Larynx, Glottic, T1, hypofractionated radiotherapy, Vocal cord, Laryngeal carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single vocal cord hypofractionated radiotherapy | Experimental | Radiation: Hypofractionated single vocal cord irradiationHypofractionated radiotherapy 58.08Gy/16 fractions to affected vocal cord plus margins to account for motion and setup errors using IMRT/VMAT technique |
| Whole laryngeal radiotherapy | Active comparator | Radiation: Whole laryngeal radiotherapyRadiotherapy 63Gy/28 fractions to whole larynx from lower border of hyoid bone to lower border of cricoid cartilage using IMRT/VMAT technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- T10N0 glottic squamous cell carcinoma
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group performance status 0-2
Key exclusion criteria (2 listed)
- Previous head and neck irradiation.
- WHO performance status above 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated single vocal cord irradiationOnly the affected vocal cord with additional margin to account for motion and setup errors will receive 58.08Gy/16 fractions using IMRT/VMAT technique | Radiation | Single vocal cord hypofractionated radiotherapy |
| Whole laryngeal radiotherapyThe whole larynx from lower border of hyoid bone to lower border of cricoid cartilage will receive 63Gy/28 fractions using IMRT/VMAT technique | Radiation | Whole laryngeal radiotherapy |
Primary outcome
Local control
Time frame: at 1 year follow up
Rate of local control
4 secondary outcomes
Voice Handicap index
Time frame: Pretreatment- 2 months 6 months 1 year and 1 year follow upn
Rates of acute toxicity
Time frame: Week 0 post-treatment and at 2-month follow-up
Rates of chronic toxicity
Time frame: at 6 months - 1 year and 2 years follow up
Overall survival
Time frame: at 2 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Background: PubMed 16169681Yamazaki 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.
- Background: PubMed 12972304Gowda 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.
- Background: PubMed 26264629Al-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.
- Background: PubMed 21300449Osman 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.
- Background: PubMed 17418971Dornfeld 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.
- Derived from this study: PubMed 41520731Elsharief MM, Hassouna AH, Shouman T, Mosallam A, El-Badrawy A, Shawky A, Amin A, Abdelfatah SM. Single vocal cord irradiation (SVCI) vs whole laryngeal radiotherapy in the treatment of T1aN0 glottic cancer A prospective randomized trial. Radiother Oncol. 2026 Mar;216:111376. doi: 10.1016/j.radonc.2026.111376. Epub 2026 Jan 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Mortada Elsharief principal investigator
NCI, Cairo University, Egypt
Tarek Shouman study chair
NCI, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated single vocal cord irradiation and Whole laryngeal radiotherapy in people with Larynx Cancer Stage I and Glottic Carcinoma, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mortada Elsharief (+0201128512966, drmohamedelcherif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: at 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05679856, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.