Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/5/2018 |
| Start Date: | October 11, 2018 |
| End Date: | December 12, 2024 |
| Contact: | Diane Trudel |
| Email: | diane.dt.trudel.chum@ssss.gouv.qc.ca |
| Phone: | 514-890-8000 |
A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage
(T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary
objective is to assess the non-inferiority of local control achieved with vocal-cord only
radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic
laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes
include overall survival, as well as voice impairment, dysphagia and quality of life,
measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia
Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN).
Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients)
arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim
analysis is planned after the first 55 patients enrolled on the experimental arm have a
6-month follow-up.
(T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary
objective is to assess the non-inferiority of local control achieved with vocal-cord only
radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic
laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes
include overall survival, as well as voice impairment, dysphagia and quality of life,
measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia
Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN).
Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients)
arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim
analysis is planned after the first 55 patients enrolled on the experimental arm have a
6-month follow-up.
Inclusion Criteria:
- Stage T1a-b N0 of the true vocal cords planned for definitive RT
- Patient not candidate for laser surgery or declined laser surgery
- Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma
- Eastern Cooperative Oncology Group performance status 0-2
- Ability to provide written informed consent.
Exclusion Criteria:
- Previous irradiation of the head and neck (HNC) region
- Pregnancy or breastfeeding
- Any medical condition that represents, in the opinion of the investigator, a
contraindication to radiotherapy or would prevent follow-up after radiotherapy.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 2 years.
We found this trial at
2
sites
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: David I Rosenthal
Phone: 877-832-6789
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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London, Ontario
Principal Investigator: David Palma
Phone: 519-685-8500
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