Clinical trial · Interventional
Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer
Vocal Cord Only Hypofractionated Radiotherapy vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer
NCT05679856CI-TRIAL-00063153VC-LarynxunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glottic Carcinoma | Glottis Carcinoma | ALIAS | 0.90 |
| Larynx Cancer Stage I | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated single vocal cord irradiation | Radiation | — | UNRESOLVED |
| Whole laryngeal radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single vocal cord hypofractionated radiotherapy
- description
- Hypofractionated radiotherapy 58.08Gy/16 fractions to affected vocal cord plus margins to account for motion and setup errors using IMRT/VMAT technique
- interventionNames
- Radiation: Hypofractionated single vocal cord irradiation
- type
- ACTIVE_COMPARATOR
- label
- Whole laryngeal radiotherapy
- description
- Radiotherapy 63Gy/28 fractions to whole larynx from lower border of hyoid bone to lower border of cricoid cartilage using IMRT/VMAT technique
- interventionNames
- Radiation: Whole laryngeal radiotherapy
Primary outcomes (1)
- measure
- Local control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDYamazaki 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
- BACKGROUNDGowda 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
- BACKGROUNDAl-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
- BACKGROUNDOsman 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
- BACKGROUNDDornfeld 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
- DERIVEDElsharief 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.