Head and Neck Cancer Clinical Trial
Official title:
Prevention of Radiation-induced Parotid Gland Dysfunction by Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy(SCS-IMRT)
Rationale:
Radiation-induced parotid gland dysfunction, often leading to xerostomia is the
most-frequently occurring side-effect with a major impact on patient-reported quality of
life after radiotherapy for head and neck cancer (HNC). Therefore, treatments for HNC are
currently optimized to minimize the mean dose to the parotid glands. Though this resulted in
a significant reduction of toxicity, 30%-40% of the patients still develop sustained parotid
gland dysfunction and xerostomia.
However, in animal studies the investigators found that the dose to the sub-volume of the
gland containing the parotid gland stem cells is a better predictor for dysfunction than the
mean dose to the whole gland. Subsequently, this finding was confirmed in a retrospective
analysis in patients. Therefore, a reduction of dose specifically in this sub-volume of the
parotid glands of patients is expected to further reduce the risk of parotid gland
dysfunction and xerostomia.
Objective:
To test the hypothesis that parotid gland stem cell sparing intensity modulated radiotherapy
in HNC patients reduces the risk of parotid gland dysfunction and xerostomia as compared to
conventional parotid gland sparing intensity modulated radiotherapy.
Study design:
Double-blind prospective randomized trial (51 patients per arm). Study population: Patients
treated for tumours in the head-and-neck region with curative radiotherapy, with or without
the addition of chemotherapy or cetuximab.
Intervention: Patients randomized into the experimental arm will receive a treatment in
which the radiation dose to the parotid gland is re-distributed to minimize dose to the
sub-volume containing the stem cells, while keeping the same mean dose to the parotid gland
as a whole.
Main study parameters/endpoints:
Primary endpoint is parotid gland salivary secretion. Secondary endpoints are patient- and
physician-rated xerostomia.
n/a
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