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Parotid-sparing IMRT for Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT02149641
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

Condition or disease Intervention/treatment
Nasopharyngeal Cancers Intensity Modulated Radiotherapy With Chemotherapy Radiation: Intensity modulated radiotherapy with chemotherapy

Detailed Description:
The purpose of this study was to determine the feasibility in delivering induction chemotherapy and concomitant chemotherapy with IMRT in the treatment of locally advanced nasopharyngeal cancers and to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Study of Parotid Sparing IMRT for Nasopharyngeal Cancer
Study Start Date : February 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Nasopharyngeal cancers
Intensitiy modulated radiotherapy with chemotherapy
Radiation: Intensity modulated radiotherapy with chemotherapy



Primary Outcome Measures :
  1. the incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Acute radiation toxicities [ Time Frame: 0-3 months ]
  2. Late radiation toxicities [ Time Frame: 3-24 months ]
  3. loco-regional disease-free survival (LRDFS), progression-free survival (PFS) and overall survival (OS) [ Time Frame: 2 years ]
  4. chemotherapy compliance and toxicities [ Time Frame: 0-12 weeks ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
nasopharyngeal cancers
Criteria

Inclusion Criteria:

  • nasopharyngeal cancers

Exclusion Criteria:

  • Patients <16 years old or with a previous malignancy other than non-melanomatous skin cancer were excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149641


Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Christopher M Nutting, FRCR Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02149641     History of Changes
Other Study ID Numbers: CCR2608
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Carcinoma