Clinical trial · Interventional
Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for Parotid Tumors
A Multicenter Randomized Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients With Parotid Tumors
- 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 kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy is more effective in decreasing hearing loss in patients undergoing radiation therapy for parotid gland cancer. PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to see how well it works compared with 3-dimensional conformal radiation therapy in decreasing hearing loss in patients who have undergone surgery for parotid tumors.
Conditions
Conditions (3)
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 |
| Ototoxicity | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| adjuvant therapy | Procedure | — | UNRESOLVED |
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients developing sensory-neural hearing loss of at least 10 dB at bone conduction as assessed by audiograms at 4000 Hz one year after treatment
Secondary outcomes (7)
- measure
- Auditory assessment at 6 and 12 months following radiotherapy (RT) and then annually thereafter for up to 5 years
- measure
- Vestibular assessment at baseline, at 6 and 12 months following RT, and then annually thereafter for up to 5 years
- measure
- Quality of life at 6 and 12 months following RT and then annually thereafter for 5 years
- measure
- Local and regional tumor control
- measure
- Time to tumor progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant tumors of the parotid glands * Adjuvant radiotherapy planned post-surgery * No parotid tumors requiring primary radiotherapy * No benign tumors requiring postoperative radiotherapy * No metastases from squamous cell carcinoma of the head and neck to the parotid gland * At high-risk of radiation-induced sensory-neural hearing loss with conventional radiotherapy due to the irradiation of the parotid bed to a dose equivalent of 60 Gy in 2 Gy/fraction with photon beams, using the wedge-pair technique PATIENT CHARACTERISTICS: * WHO performance status 0-1 * No hearing loss \> 60 dB * No previous or concurrent illness that, in the investigator's opinion, would interfere with either completion of therapy or follow-up * Suitable to attend regular follow-up and undergo audiograms and toxicity monitoring and be available for long term follow-up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy to the head and neck region * No concurrent chemotherapy
References
Publications (0)
Data not yet available