A Phase 3 interventional study of adjuvant therapy and assessment of therapy complications in Head and Neck Cancer, Ototoxicity and Radiation Toxicity, sponsored by Institute of Cancer Research, United Kingdom. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-07.
Sponsored by Institute of Cancer Research, United Kingdom · Phase 3, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy is more effective in decreasing hearing loss in patients undergoing radiation therapy for parotid gland cancer.
PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to see how well it works compared with 3-dimensional conformal radiation therapy in decreasing hearing loss in patients who have undergone surgery for parotid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to center and radiotherapy dose. Patients are randomized to 1 of 2 treatment arms after surgical resection.
Patients complete quality-of-life questionnaires (EORTC QLQC30 v.3.0, the head and neck module H\&N35, and a modified version of the Glasgow Hearing Aid Benefit profile) at baseline and at 6,12, 24, 36, 48, and 60 months after completion of study therapy. Patients also undergo audiological and vestibular assessment at 6 and 12 months following radiotherapy and then annually thereafter for up to 5 years.
After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months and then annually thereafter for up to 5 years (annually for recurrence for at least 10 years).
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 84 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Institute of Cancer Research, United Kingdom is the lead sponsor of 113 studies on the registry; 27 are open to participants now.
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proportion of patients developing sensory-neural hearing loss of at least 10 dB at bone conduction as assessed by audiograms at 4000 Hz one year after treatment
Auditory assessment at 6 and 12 months following radiotherapy (RT) and then annually thereafter for up to 5 years
Vestibular assessment at baseline, at 6 and 12 months following RT, and then annually thereafter for up to 5 years
Quality of life at 6 and 12 months following RT and then annually thereafter for 5 years
Local and regional tumor control
Time to tumor progression
Overall survival
Acute and late side effects of RT as assessed by NCI CTCAE v 3.0 and the LENT SOMA and late RT scoring systems
The record gives a start of Aug 2008 and a primary completion of Aug 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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