Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00081029
First received: April 7, 2004
Last updated: March 22, 2011
Last verified: March 2008
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths directly to the tumor from many angles. This type of radiation therapy may reduce damage to the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality of life. It is not yet known whether intensity-modulated radiation therapy is more effective than conventional radiation therapy in preventing xerostomia and improving quality of life in patients who have throat cancer.

PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to see how well it works compared to conventional radiation therapy in treating patients with oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused by radiation therapy.


Condition Intervention Phase
Head and Neck Cancer
Radiation Toxicity
Xerostomia
Procedure: management of therapy complications
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Degree of xerostomia by salivary flow at 1 year [ Designated as safety issue: No ]
  • Xerosomia-related quality of life by Modified Xerostomia questionnaire at 1 year [ Designated as safety issue: No ]
  • Quality of Life by EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires at 1 year [ Designated as safety issue: No ]
  • Local and regional tumor control by a quantitative description of sites of relapse at 1 year [ Designated as safety issue: No ]
  • Time to tumor progression at 1 year [ Designated as safety issue: No ]
  • Overall survival at 1 year [ Designated as safety issue: No ]
  • Acuteside effects of radiotherapy by NCI CTCAE scale v. 3.0 at 1 year [ Designated as safety issue: Yes ]
  • Late side effects of radiotherapy by NCI CTCAE scale v3.0, LENT SOMA and RTOG at 1 year [ Designated as safety issue: Yes ]

Estimated Enrollment: 84
Study Start Date: January 2004
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Compare the proportion of patients with oropharyngeal or hypopharyngeal cancer with xerostomia of ≥ grade 2 at one year after treatment with parotid-sparing intensity-modulated radiotherapy vs conventional radiotherapy.

Secondary

  • Compare the degree of xerostomia by quantitative measurements of stimulated and unstimulated salivary flow in patients treated with these regimens.
  • Compare quality of life in patients treated with these regimens.
  • Compare local and regional tumor control, time to tumor progression, and overall survival of patients treated with these regimens.
  • Compare acute and late side effects of these regimens in these patients.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and site of disease (oropharynx vs hypopharynx). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo parotid-sparing intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks.
  • Arm II: Patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.

Salivary flow measurements are performed at baseline, at week 4 during radiotherapy, and then at 2 weeks and at 3, 6, 12, and 24 months after the completion of radiotherapy.

Quality of life is assessed at baseline, at 2 weeks, and then at 3, 6, 12, 18, and 24 months after the completion of radiotherapy.

Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed oropharyngeal or hypopharyngeal cancer

    • Squamous cell or undifferentiated carcinoma
    • Stage T1-4, N0-3, M0 disease
  • Primary tumor requiring radical radiotherapy with parallel opposed lateral fields and bilateral cervical lymph node irradiation

    • Radiotherapy is either the primary therapy or post-operative (adjuvant irradiation) treatment
  • High-risk for radiation-induced xerostomia with conventional radiotherapy due to irradiation of the majority of both parotid glands* NOTE: *Estimated mean dose to both parotid glands is greater than 24 Gy by conventional radiotherapy
  • No bilateral N3 nodal disease
  • No huge primary tumor (exceeding 10 cm in diameter)
  • No contralateral lymphadenopathy adjacent to or involving contralateral parotid gland making parotid sparing impossible
  • No tumor at the base of the tongue where sparing of contralateral parapharyngeal space is contraindicated

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Able to undergo quality of life and salivary flow measurements (dependent on cognitive aptitude and long availability)
  • Able to complete self-assessed quality of life questionnaire
  • No prior or concurrent illness that would preclude study participation
  • No pre-existing salivary gland pathology interfering with saliva production
  • No other prior malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Prior neoadjuvant chemotherapy allowed
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy to the head and neck region
  • No concurrent brachytherapy

Surgery

  • See Disease Characteristics

Other

  • No concurrent prophylactic amifostine or pilocarpine
  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: NCT00081029

Locations
United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom, HU8 9HE
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Barts and the London School of Medicine
London, England, United Kingdom, EC1M 6BQ
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
University College Hospital - London
London, England, United Kingdom, WC1E 6AU
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
University Hospital of North Staffordshire
Stoke-On-Trent, England, United Kingdom, ST4 7LN
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Study Chair: Chris Nutting Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00081029     History of Changes
Other Study ID Numbers: CDR0000358803, ICR-PARSPORT, EU-20304, ISRCTN48243537, MREC-03679
Study First Received: April 7, 2004
Last Updated: March 22, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
xerostomia
radiation toxicity
stage I squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the oropharynx

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

ClinicalTrials.gov processed this record on October 23, 2014