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NCT00081029 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2011-03-23

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    management of therapy complications
    type
    PROCEDURE
  2. name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
84
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year
secondary Outcomes
  1. measure
    Degree of xerostomia by salivary flow at 1 year
  2. measure
    Xerosomia-related quality of life by Modified Xerostomia questionnaire at 1 year
  3. measure
    Quality of Life by EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires at 1 year
  4. measure
    Local and regional tumor control by a quantitative description of sites of relapse at 1 year
  5. measure
    Time to tumor progression at 1 year
  6. measure
    Overall survival at 1 year
  7. measure
    Acuteside effects of radiotherapy by NCI CTCAE scale v. 3.0 at 1 year
  8. measure
    Late side effects of radiotherapy by NCI CTCAE scale v3.0, LENT SOMA and RTOG at 1 year
Full study description
brief 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. 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.
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.
Source references
references
  1. citation
    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.
    pmid
    21236730
    type
    RESULT
  2. citation
    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.
    pmid
    19596158
    type
    RESULT
  3. citation
    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.
    pmid
    19332518
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        rence was observed between the different dose-escalated groups.</li></ul></div></li><li>A randomized trial (<a href="/clinicaltrials/NCT00081029">PARSPORT</a> [NCT00081029]) conducted in the United Kingdom compared conventional 3-dimensional conformal radiation therapy with IMRT. The following results were observed:[<a href="#ci
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      source title
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice