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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Ototoxicity, Radiation Toxicity

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome 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

Safety Issue:

Yes

Principal Investigator

Chris Nutting

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000686212

NCT ID:

NCT01216800

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Ototoxicity
  • Radiation Toxicity
  • ototoxicity
  • radiation toxicity
  • stage I salivary gland cancer
  • stage II salivary gland cancer
  • stage III salivary gland cancer
  • Head and Neck Neoplasms
  • Parotid Neoplasms
  • Radiation Injuries

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