Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for Parotid Tumors

NCT01216800 | Unknown Phase 3

• 7 other identifiers: CDR0000686212ICR-CTSU/2007/10012ISRCTN-81772291EU-21073MREC-05/Q0801/183CRUK-08/004ICR-RMH-2708
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Cancer; Ototoxicity; Radiation Toxicity

Keywords

ototoxicity; radiation toxicity; stage I salivary gland cancer; stage II salivary gland cancer; stage III salivary gland cancer

Outcome Measures

Primary Outcomes (1)

• 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)

• Auditory assessment at 6 and 12 months following radiotherapy (RT) and then annually thereafter for up to 5 years

• Vestibular assessment at baseline, at 6 and 12 months following RT, and then annually thereafter for up to 5 years

• Quality of life at 6 and 12 months following RT and then annually thereafter for 5 years

• Local and regional tumor control

• Time to tumor progression

Interventions

adjuvant therapy PROCEDURE

assessment of therapy complications PROCEDURE

quality-of-life assessment PROCEDURE

3-dimensional conformal radiation therapy RADIATION

intensity-modulated radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Ototoxicity; Radiation Injuries; Salivary Gland Neoplasms

Interventions

Chemotherapy, Adjuvant; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Wounds and Injuries; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• Chris Nutting

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2016
• Last Updated: October 7, 2010

Record last verified: 2010-10

Locations

GB (1)