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

NCT00081029 | Unknown Phase 3

• 5 other identifiers: CDR0000358803ICR-PARSPORTEU-20304ISRCTN48243537MREC-03679
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 9

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.

Conditions

Head and Neck Cancer; Radiation Toxicity; Xerostomia

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• Degree of xerostomia by salivary flow at 1 year

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

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

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

• Time to tumor progression at 1 year

Interventions

management of therapy complications PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (9)

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Barts and the London School of Medicine

London, England, EC1M 6BQ, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

University College Hospital - London

London, England, WC1E 6AU, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-on-Trent, England, ST4 7LN, United Kingdom

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries; Xerostomia; Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chris Nutting

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: January 1, 2004
• Primary Completion: January 1, 2013
• Last Updated: March 23, 2011

Record last verified: 2008-03

Locations

GB (9)