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AzTrials

Head and Neck CancerPhase 3NCT00081029

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

A Phase 3 study testing management of therapy complications and radiation therapy in people with Head and Neck Cancer and Radiation Toxicity, run by Royal Marsden NHS Foundation Trust at 9 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
management of therapy complications and radiation therapy
Type of treatment
Surgery or procedure
How many people
84 participants
Where
9 sitesUnited Kingdom
Study dates
Jan 2004to Jan 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United Kingdom9 sites

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust

    Hull, England, HU8 9HE

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • Barts and the London School of Medicine

    London, England, EC1M 6BQ

  • Royal Marsden - London

    London, England, SW3 6JJ

  • University College Hospital - London

    London, England, WC1E 6AU

  • Christie Hospital

    Manchester, England, M20 4BX

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • University Hospital of North Staffordshire

    Stoke-on-Trent, England, ST4 7LN

Other trials in United Kingdom

About this study

Official title: A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer

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.

Read the 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.

Being tested
management of therapy complications, radiation therapy
Keywords
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
Medical subject headings
Head and Neck Neoplasms, Radiation Injuries, Xerostomia, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • management of therapy complicationsProcedure or surgery

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year

Secondary outcomes (8)

  1. Degree of xerostomia by salivary flow at 1 year

  2. Xerosomia-related quality of life by Modified Xerostomia questionnaire at 1 year

  3. Quality of Life by EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires at 1 year

  4. Local and regional tumor control by a quantitative description of sites of relapse at 1 year

  5. Time to tumor progression at 1 year

  6. Overall survival at 1 year

  7. Acuteside effects of radiotherapy by NCI CTCAE scale v. 3.0 at 1 year

  8. Late side effects of radiotherapy by NCI CTCAE scale v3.0, LENT SOMA and RTOG at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionJan 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081029
Sponsor's protocol ID
CDR0000358803
Other IDs
ICR-PARSPORT, EU-20304, ISRCTN48243537, MREC-03679
Status last verified
Mar 2008
First submitted
7 Apr 2004
Last updated
23 Mar 2011
Results posted
No

Publications

  • Nutting CM, Morden JP, Harrington KJ, Urbano TG, Bhide SA, Clark C, Miles EA, Miah AB, Newbold K, Tanay M, Adab F, Jefferies SJ, Scrase C, Yap BK, A'Hern RP, Sydenham MA, Emson M, Hall E; PARSPORT trial management group. Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2011 Feb;12(2):127-36. doi: 10.1016/S1470-2045(10)70290-4. Epub 2011 Jan 12.

    PubMed 21236730

  • Clark CH, Hansen VN, Chantler H, Edwards C, James HV, Webster G, Miles EA, Guerrero Urbano MT, Bhide SA, Bidmead AM, Nutting CM; PARSPORT Trial Management Group. Dosimetry audit for a multi-centre IMRT head and neck trial. Radiother Oncol. 2009 Oct;93(1):102-8. doi: 10.1016/j.radonc.2009.04.025.

    PubMed 19596158

  • Clark CH, Miles EA, Urbano MT, Bhide SA, Bidmead AM, Harrington KJ, Nutting CM; UK PARSPORT Trial Management Group collaborators. Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer. Br J Radiol. 2009 Jul;82(979):585-94. doi: 10.1259/bjr/31966505. Epub 2009 Mar 30.

    PubMed 19332518

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing management of therapy complications and radiation therapy in people with Head and Neck Cancer and Radiation Toxicity, run by Royal Marsden NHS Foundation Trust at 9 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00081029, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011.

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