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

Head and Neck Cancer Clinical Trial

Official title:

A Multicenter Randomized Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients With Parotid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01216800
• Other study ID #: CDR0000686212
• Secondary ID: ICR-CTSU/2007/10
• Status: Recruiting
• Phase: Phase 3
• First received: October 6, 2010
• Last updated: October 6, 2010
• Start date: August 2008

Study information

• Verified date: October 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• To determine the potential of cochlear-sparing intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy comprising 3-dimensional conformal radiotherapy in reducing the incidence of sensory-neural hearing loss in patients with parotid tumors undergoing radiotherapy to the parotid region.

Secondary

• To describe and compare the impact of both IMRT and conventional radiotherapy on physical, social and emotional well-being including generic functional and symptom aspects as well as disease-specific issues relevant to audiometry.

OUTLINE: This is a multicenter study. Patients are stratified according to center and radiotherapy dose. Patients are randomized to 1 of 2 treatment arms after surgical resection.

• Arm I (cochlear-sparing intensity-modulated radiotherapy [IMRT]): Patients undergo cochlear-sparing IMRT using the local planning system once daily, 5 days per week, for 6 weeks (total of 30 fractions) at a total dose of 60 Gy (65 Gy if macroscopic residual disease). Patients may undergo elective neck irradiation of the uninvolved lymph node areas once daily, 5 days per week, for 6 weeks.

• Arm II (conventional radiotherapy): Patients undergo conventional radiotherapy comprising 3-dimensional conformal radiotherapy once daily, 5 days per week, for 6 weeks (total of 30 fractions) at a total dose of 60 Gy (65 Gy if macroscopic residual disease). Patients may undergo elective neck irradiation of the uninvolved lymph node areas once daily, 5 days a week, for 5 weeks.

Patients complete quality-of-life questionnaires (EORTC QLQC30 v.3.0, the head and neck module H&N35, and a modified version of the Glasgow Hearing Aid Benefit profile) at baseline and at 6,12, 24, 36, 48, and 60 months after completion of study therapy. Patients also undergo audiological and vestibular assessment at 6 and 12 months following radiotherapy and then annually thereafter for up to 5 years.

After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months and then annually thereafter for up to 5 years (annually for recurrence for at least 10 years).

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Ototoxicity
• Parotid Neoplasms
• Radiation Injuries
• Radiation Toxicity

Intervention

Procedure:
• adjuvant therapy

• assessment of therapy complications

• quality-of-life assessment

Radiation:
• 3-dimensional conformal radiation therapy

• intensity-modulated radiation therapy

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - London	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			Yes
Secondary	Auditory assessment at 6 and 12 months following radiotherapy (RT) and then annually thereafter for up to 5 years			No
Secondary	Vestibular assessment at baseline, at 6 and 12 months following RT, and then annually thereafter for up to 5 years			No
Secondary	Quality of life at 6 and 12 months following RT and then annually thereafter for 5 years			No
Secondary	Local and regional tumor control			No
Secondary	Time to tumor progression			No
Secondary	Overall survival			No
Secondary	Acute and late side effects of RT as assessed by NCI CTCAE v 3.0 and the LENT SOMA and late RT scoring systems			Yes