Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy

Head and Neck Cancer Clinical Trial

— SCS-IMRT  

Official title:

Prevention of Radiation-induced Parotid Gland Dysfunction by Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy(SCS-IMRT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955239
• Other study ID #: RT2011-04
• Status: Completed
• Phase: N/A
• First received: September 27, 2013
• Last updated: June 21, 2017
• Start date: September 2013
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• Intensity-modulated Radiotherapy

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Oct 13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary flow		12 months after radiotherapy
Secondary	Patient-rated Xerostomia		12 months after radiotherapy