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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01216800
First received: October 6, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Ototoxicity
Radiation Toxicity
Procedure: adjuvant therapy
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients With Parotid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Auditory assessment at 6 and 12 months following radiotherapy (RT) and then annually thereafter for up to 5 years [ Designated as safety issue: No ]
  • Vestibular assessment at baseline, at 6 and 12 months following RT, and then annually thereafter for up to 5 years [ Designated as safety issue: No ]
  • Quality of life at 6 and 12 months following RT and then annually thereafter for 5 years [ Designated as safety issue: No ]
  • Local and regional tumor control [ Designated as safety issue: No ]
  • Time to tumor progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Acute and late side effects of RT as assessed by NCI CTCAE v 3.0 and the LENT SOMA and late RT scoring systems [ Designated as safety issue: Yes ]

Estimated Enrollment: 84
Study Start Date: August 2008
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216800

Locations
United Kingdom
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Contact Person    44-20-8722-4104    chris.nutting@rmh.nhs.uk   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Principal Investigator: Chris Nutting Royal Marsden NHS Foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01216800     History of Changes
Other Study ID Numbers: CDR0000686212, ICR-CTSU/2007/10012, ISRCTN-81772291, EU-21073, MREC-05/Q0801/183, CRUK-08/004, ICR-RMH-2708
Study First Received: October 6, 2010
Last Updated: October 6, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ototoxicity
radiation toxicity
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer

Additional relevant MeSH terms:
Parotid Diseases
Head and Neck Neoplasms
Parotid Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Salivary Gland Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 24, 2014