Clinical trial · Interventional
Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
NCT00002727CI-TRIAL-00025339completedPhase 3ClinicalTrials.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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord. PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiation therapy - conventional fractionation
- description
- Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
- interventionNames
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Radiation therapy - hyperfractionation
- description
- Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Local Control
- timeFrame
- From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven invasive squamous cell carcinoma of the true vocal cord * Stage II (T2a/b N0) disease with bulk of tumor present on vocal cord (i.e., the epicenter) with extension to adjacent areas * No verrucal carcinoma or adenocarcinoma * No extension to pre-epiglottic space or pyriform sinus * No fixed cord or cartilage invasion * No evidence of adenopathy, including any of the following: * Nodes larger than 1 cm by radiography * Nodes containing a low central density consistent with necrosis by radiography * Clinically palpable nodes larger than 1 cm and firm in consistency * No recurrent or persistent disease * No evidence or suspicion of distant metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy within the past 5 years except nonmelanomatous skin cancer * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to the mid-neck or larynx Surgery: * No prior complete stripping or laser excision of all gross disease
References
Publications (0)
Data not yet available
No reference posted for this study.