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Head and Neck CancerSCS-IMRTNCT01955239

Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy

A study testing Intensity-modulated Radiotherapy in people with Head and Neck Cancer, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Intensity-modulated Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteNetherlands
Study dates
Sep 2013to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Postoperative radiotherapy;
  • Previous radiotherapy of the head and neck region (re-irradiation);
  • Unilateral radiotherapy;
  • Primary salivary gland tumours

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700RB

Other trials in Netherlands

About this study

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.

Read more

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.

Being tested
Intensity-modulated Radiotherapy
Keywords
Head and Neck Cancer, Radiotherapy, IMRT, Stem cell, Parotid gland
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity-modulated RadiotherapyRadiation

Study groups in NCT01955239
Study groupRoleWhat they receive
Standard IMRTActive comparatorStandard IMRT in which the mean dose to both whole parotid glands is minimized.
Receives: Radiation: Intensity-modulated Radiotherapy
Stem-cell Sparing IMRTExperimentalStem-cell Sparing IMRT in which the mean dose to the stem cell containing region of the parotid gland is minimized
Receives: Radiation: Intensity-modulated Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary flow

    Measured: 12 months after radiotherapy

Secondary outcomes (1)

  1. Patient-rated Xerostomia

    Measured: 12 months after radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01955239
Sponsor's protocol ID
RT2011-04
Acronym
SCS-IMRT
Status last verified
Jun 2017
First submitted
27 Sep 2013
Last updated
22 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 18669465

  • 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.

    PubMed 22516776

  • 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.

    PubMed 19787001

  • 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.

    PubMed 15990013

  • 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.

    PubMed 16226398

  • 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.

    PubMed 18446241

  • 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.

    PubMed 18669914

  • 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.

    PubMed 25519706

Questions about this trial

What is this clinical trial studying?

A study testing Intensity-modulated Radiotherapy in people with Head and Neck Cancer, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary flow (time frame: 12 months after radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01955239, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.

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