- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01955239
Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy (SCS-IMRT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Groningen, Netherlands, 9700RB
- University Medical Center Groningen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Squamous cell carcinoma originating from the mucosa of the head and neck area or nasopharyngeal carcinoma originating from the nasopharynx;
- The radiotherapy includes prophylactic or therapeutic irradiation of both sides of the neck (at least level II to IV);
- Age ≥ 18 years;
- WHO performance 0-2;
- To reduce the uncertainty in the assessment of relative flow after treatment, pre-treatment parotid gland saliva production stimulated with 5% citric acid should exceed >0.1 ml/min
Exclusion Criteria:
- Postoperative radiotherapy;
- Previous radiotherapy of the head and neck region (re-irradiation);
- Unilateral radiotherapy;
- Primary salivary gland tumours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard IMRT
Standard IMRT in which the mean dose to both whole parotid glands is minimized.
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Experimental: Stem-cell Sparing IMRT
Stem-cell Sparing IMRT in which the mean dose to the stem cell containing region of the parotid gland is minimized
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Salivary flow
Time Frame: 12 months after radiotherapy
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12 months after radiotherapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient-rated Xerostomia
Time Frame: 12 months after radiotherapy
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12 months after radiotherapy
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Collaborators and Investigators
Publications and helpful links
General Publications
- Langendijk JA, Doornaert P, Verdonck-de Leeuw IM, Leemans CR, Aaronson NK, Slotman BJ. Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy. J Clin Oncol. 2008 Aug 1;26(22):3770-6. doi: 10.1200/JCO.2007.14.6647.
- Beetz I, Schilstra C, van der Schaaf A, van den Heuvel ER, Doornaert P, van Luijk P, Vissink A, van der Laan BF, Leemans CR, Bijl HP, Christianen ME, Steenbakkers RJ, Langendijk JA. NTCP models for patient-rated xerostomia and sticky saliva after treatment with intensity modulated radiotherapy for head and neck cancer: the role of dosimetric and clinical factors. Radiother Oncol. 2012 Oct;105(1):101-6. doi: 10.1016/j.radonc.2012.03.004. Epub 2012 Apr 18.
- Eisbruch A. Radiotherapy: IMRT reduces xerostomia and potentially improves QoL. Nat Rev Clin Oncol. 2009 Oct;6(10):567-8. doi: 10.1038/nrclinonc.2009.143. No abstract available.
- Konings AW, Cotteleer F, Faber H, van Luijk P, Meertens H, Coppes RP. Volume effects and region-dependent radiosensitivity of the parotid gland. Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):1090-5. doi: 10.1016/j.ijrobp.2004.12.035.
- Konings AW, Faber H, Cotteleer F, Vissink A, Coppes RP. Secondary radiation damage as the main cause for unexpected volume effects: a histopathologic study of the parotid gland. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):98-105. doi: 10.1016/j.ijrobp.2005.06.042. Epub 2005 Oct 13.
- Lombaert IM, Brunsting JF, Wierenga PK, Faber H, Stokman MA, Kok T, Visser WH, Kampinga HH, de Haan G, Coppes RP. Rescue of salivary gland function after stem cell transplantation in irradiated glands. PLoS One. 2008 Apr 30;3(4):e2063. doi: 10.1371/journal.pone.0002063.
- Lombaert IM, Brunsting JF, Wierenga PK, Kampinga HH, de Haan G, Coppes RP. Keratinocyte growth factor prevents radiation damage to salivary glands by expansion of the stem/progenitor pool. Stem Cells. 2008 Oct;26(10):2595-601. doi: 10.1634/stemcells.2007-1034. Epub 2008 Jul 31.
- Doornaert P, Dahele M, Ljumanovic R, de Bree R, Slotman BJ, Castelijns JA. Use of diffusion-weighted magnetic resonance imaging (DW-MRI) to investigate the effect of chemoradiotherapy on the salivary glands. Acta Oncol. 2015 Jul;54(7):1068-71. doi: 10.3109/0284186X.2014.987357. Epub 2014 Dec 18. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RT2011-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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